The following data is part of a premarket notification filed by Safeskin Corp. with the FDA for Safeskin Supra.
Device ID | K953015 |
510k Number | K953015 |
Device Name: | SAFESKIN SUPRA |
Classification | Surgeon's Gloves |
Applicant | SAFESKIN CORP. 6815 FLANDERS DR. San Diego, CA 92121 |
Contact | Wava Truscott |
Correspondent | Wava Truscott SAFESKIN CORP. 6815 FLANDERS DR. San Diego, CA 92121 |
Product Code | KGO |
CFR Regulation Number | 878.4460 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-06-29 |
Decision Date | 1995-08-28 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SAFESKIN SUPRA 74549262 1953750 Dead/Cancelled |
SAFESKIN CORPORATION 1994-07-14 |