GBJ · Class I · 21 CFR 878.3750

FDA Product Code GBJ: Prosthesis, Adhesive, External

Leading manufacturers include Jelco Laboratories and Trulife , Ltd..

4

Total

4

Cleared

31d

Avg days

1979

Since

FDA 510(k) Cleared Prosthesis, Adhesive, External Devices (Product Code GBJ)

4 devices

1–4 of 4

Cleared Dec 10, 1993

General & Plastic Surgery · 53d

Cleared Feb 26, 1979

PROTECTIVSTABILIZER

Jelco Laboratories

General & Plastic Surgery · 28d

About Product Code GBJ - Regulatory Context

Related FDA 510(k) Regulatory Insights

Data Source

FDA 510(k) public files . 176,325 total devices indexed.

Latest clearance: Dec 10, 1993

Product Code Info

Code	GBJ
Device class	Class I
CFR	21 CFR 878.3750
Panel	General & Plastic Surgery

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View GBJ classification on FDA.gov →