The following data is part of a premarket notification filed by Arjo Wiggins Medical, Inc. with the FDA for Sterilization Wrap-sterisheet.
Device ID | K931202 |
510k Number | K931202 |
Device Name: | STERILIZATION WRAP-STERISHEET |
Classification | Wrap, Sterilization |
Applicant | ARJO WIGGINS MEDICAL, INC. SUSAN B. HOWARD P.O. BOX 2010 Palm Harbor, FL 34682 |
Contact | R.m.s., Inc. |
Correspondent | R.m.s., Inc. ARJO WIGGINS MEDICAL, INC. SUSAN B. HOWARD P.O. BOX 2010 Palm Harbor, FL 34682 |
Product Code | FRG |
CFR Regulation Number | 880.6850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-03-09 |
Decision Date | 1993-12-16 |