Standard Chin

FDA 510(k) K983754 · Surgical Technology Laboratories, Inc.

Substantially Equivalent

510(k) numberK983754

Submission

Device name
Standard Chin
Applicant
Surgical Technology Laboratories, Inc.
Cleveland, OH, US
Received
October 22, 1998
Decision date
November 20, 1998
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
FWP – Prosthesis, Chin, Internal
Device class
Class II (moderate risk)
Regulation
21 CFR 878.3550
Specialty
General, Plastic Surgery
Implant
Yes

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Questions and answers

When was Standard Chin cleared by the FDA?

Standard Chin (K983754) received a 510(k) decision of Substantially Equivalent on November 20, 1998, 29 days after the submission was received.

What is the product code of K983754?

The FDA product code is FWP – Prosthesis, Chin, Internal, a Class II (moderate risk) device regulated under 21 CFR 878.3550.