Who is the manufacturer of GENT-L-KARE(TM) STERILE, PRESSURE SORE MANAGE KIT?

Premium Plastics, Inc. filed the 510(k) submission for GENT-L-KARE(TM) STERILE, PRESSURE SORE MANAGE KIT (K890107).

What is the FDA product code for GENT-L-KARE(TM) STERILE, PRESSURE SORE MANAGE KIT?

FRO. as a Class U device in the SU panel.

What is the regulatory pathway for GENT-L-KARE(TM) STERILE, PRESSURE SORE MANAGE KIT?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like GENT-L-KARE(TM) STERILE, PRESSURE SORE MANAGE KIT?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

GENT-L-KARE(TM) STERILE, PRESSURE SORE MANAGE KIT

K890107 · Premium Plastics, Inc. · FRO · Oct 24, 1989 · SU

Device Facts

Record ID	K890107
Device Name	GENT-L-KARE(TM) STERILE, PRESSURE SORE MANAGE KIT
Applicant	Premium Plastics, Inc.
Product Code	FRO · SU
Decision Date	Oct 24, 1989
Decision	SESD
Submission Type	Traditional
Device Class	Class U

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