The following data is part of a premarket notification filed by Anacapa Technologies, Inc. with the FDA for Silver Shield Antimicrobial Skin And Wound Gel, Model 3015-s.
Device ID | K062212 |
510k Number | K062212 |
Device Name: | SILVER SHIELD ANTIMICROBIAL SKIN AND WOUND GEL, MODEL 3015-S |
Classification | Dressing, Wound, Drug |
Applicant | ANACAPA TECHNOLOGIES, INC. 301 E. ARROW HWY STE. 106 San Dimas, CA 91773 |
Contact | Ila Doshi |
Correspondent | Ila Doshi ANACAPA TECHNOLOGIES, INC. 301 E. ARROW HWY STE. 106 San Dimas, CA 91773 |
Product Code | FRO |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-08-01 |
Decision Date | 2006-11-21 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00367180300031 | K062212 | 000 |
00367180312157 | K062212 | 000 |
00856040008878 | K062212 | 000 |
00856040008854 | K062212 | 000 |