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Implant, Absorbable, (Scleral Buckling Methods)

Page Type
Product Code
Regulation Medical Specialty
Ophthalmic
Review Panel
Ophthalmic
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
886.3300
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 886.3300 Absorbable implant (scleral buckling method)

§ 886.3300 Absorbable implant (scleral buckling method).

(a) Identification. An absorbable implant (scleral buckling method) is a device intended to be implanted on the sclera to aid retinal reattachment.

(b) Classification. Class II.

Implant, Absorbable, (Scleral Buckling Methods)

Page Type
Product Code
Regulation Medical Specialty
Ophthalmic
Review Panel
Ophthalmic
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
886.3300
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 886.3300 Absorbable implant (scleral buckling method)

§ 886.3300 Absorbable implant (scleral buckling method).

(a) Identification. An absorbable implant (scleral buckling method) is a device intended to be implanted on the sclera to aid retinal reattachment.

(b) Classification. Class II.