The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Sting Skin Prep Wipe(59420600)/sting Skin Prep Swab (59420700).
Device ID | K973228 |
510k Number | K973228 |
Device Name: | STING SKIN PREP WIPE(59420600)/STING SKIN PREP SWAB (59420700) |
Classification | Bandage, Liquid |
Applicant | SMITH & NEPHEW, INC. 11775 STARKEY RD. Largo, FL 33773 -4727 |
Contact | Jim G Irvin |
Correspondent | Jim G Irvin SMITH & NEPHEW, INC. 11775 STARKEY RD. Largo, FL 33773 -4727 |
Product Code | KMF |
CFR Regulation Number | 880.5090 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-08-27 |
Decision Date | 1997-11-25 |
Summary: | summary |