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 |