The following data is part of a premarket notification filed by Anacapa Technologies, Inc. with the FDA for Anasept Antimicrobial Skin And Wound Cleansers; Anasept Antimicrobial Skin And Wound Gel.
| Device ID | K073547 |
| 510k Number | K073547 |
| Device Name: | ANASEPT ANTIMICROBIAL SKIN AND WOUND CLEANSERS; ANASEPT ANTIMICROBIAL SKIN AND WOUND GEL |
| 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 | Yes |
| Date Received | 2007-12-18 |
| Decision Date | 2008-04-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00367180426168 | K073547 | 000 |
| 00856040008809 | K073547 | 000 |
| 00856040008786 | K073547 | 000 |
| 10856040008448 | K073547 | 000 |
| 10856040008431 | K073547 | 000 |
| 10856040008424 | K073547 | 000 |
| 10856040008417 | K073547 | 000 |
| 10856040008400 | K073547 | 000 |
| 10856040008394 | K073547 | 000 |
| 10856040008387 | K073547 | 000 |
| 00856040008823 | K073547 | 000 |
| 10857278000914 | K073547 | 000 |
| 10857278000921 | K073547 | 000 |
| 00367180412802 | K073547 | 000 |
| 00367180412086 | K073547 | 000 |
| 00367180512038 | K073547 | 000 |
| 00367180412123 | K073547 | 000 |
| 00367180512151 | K073547 | 000 |
| 00367180412161 | K073547 | 000 |
| 00367180400045 | K073547 | 000 |
| 00367180400441 | K073547 | 000 |
| 00367180412888 | K073547 | 000 |
| 00856040008373 | K073547 | 000 |