GAS PLASMA STERILIZATION

Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer

The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Gas Plasma Sterilization.

Device ID	K944538
510k Number	K944538
Device Name:	GAS PLASMA STERILIZATION
Classification	Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer
Applicant	DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988
Contact	David A Kotkovetz
Correspondent	David A Kotkovetz DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988
Product Code	HRY
Subsequent Product Code	HSX
Subsequent Product Code	JDB
Subsequent Product Code	JDI
Subsequent Product Code	JWH
Subsequent Product Code	KWT
CFR Regulation Number	888.3530 [🔎]
Decision	Substantially Equivalent (SESE)
Type	Traditional
3rd Party Reviewed	No
Combination Product	No
Date Received	1994-09-15
Decision Date	1995-09-26