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FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Diagnostic Devices
CFR Sub-Part
General Hospital and Personal Use Miscellaneous Devices
CFR Sub-Part
General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
NUP
Cream, Nasal, Topical, Mechanical Allergen Particle Barrier
2
Product Code
K
20
1734
AllerBlock Junior
2
Cleared 510(K)
K
17
0848
Alzair Allergy Blocker
2
Cleared 510(K)
K
13
4003
RHINIX NASAL FILTER
2
Cleared 510(K)
K
13
2520
NASAL EASE ALLERGY BLOCKER
2
Cleared 510(K)
K
12
0894
HAYMAX
2
Cleared 510(K)
K
05
3625
NASALGUARD
2
Cleared 510(K)
K
04
2610
DR. THEISS ALERGOL POLLEN BLOCKER CREAM
2
Cleared 510(K)
Miscellaneous
Miscellaneous
Miscellaneous Devices
CFR Sub-Part
Neurological Surgical Devices
CFR Sub-Part
Prosthetic Devices
CFR Sub-Part
Surgical Devices
CFR Sub-Part
Therapeutic Devices
CFR Sub-Part
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 26 May 2023 at 11:04 pm
EN
/
general-hospital-and-personal-use-therapeutic-devices
/
NUP
/
K201734
View Source
AllerBlock Junior
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K201734
510(k) Type
Traditional
Applicant
Nasaleze International Ltd
Country
Isle of Man
FDA Decision
Substantially Equivalent
Decision Date
3/26/2021
Days to Decision
274 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Diagnostic Devices
General Hospital and Personal Use Miscellaneous Devices
General Hospital and Personal Use Therapeutic Devices
NUP
Cream, Nasal, Topical, Mechanical Allergen Particle Barrier
K
20
1734
AllerBlock Junior
K
17
0848
Alzair Allergy Blocker
K
13
4003
RHINIX NASAL FILTER
K
13
2520
NASAL EASE ALLERGY BLOCKER
K
12
0894
HAYMAX
K
05
3625
NASALGUARD
K
04
2610
DR. THEISS ALERGOL POLLEN BLOCKER CREAM
Miscellaneous
Miscellaneous Devices
Neurological Surgical Devices
Prosthetic Devices
Surgical Devices
Therapeutic Devices
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
EN
/
general-hospital-and-personal-use-therapeutic-devices
/
NUP
/
K201734
View Source
AllerBlock Junior
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K201734
510(k) Type
Traditional
Applicant
Nasaleze International Ltd
Country
Isle of Man
FDA Decision
Substantially Equivalent
Decision Date
3/26/2021
Days to Decision
274 days
Submission Type
Summary