The following data is part of a premarket notification filed by Arjo Wiggins Medical, Inc. with the FDA for Arjowrap 47/100 And 47/88.
| Device ID | K062100 |
| 510k Number | K062100 |
| Device Name: | ARJOWRAP 47/100 AND 47/88 |
| Classification | Wrap, Sterilization |
| Applicant | ARJO WIGGINS MEDICAL, INC. 962 ALLEGRO LANE Apollo Beach, FL 33572 |
| Contact | Arthur Ward |
| Correspondent | Arthur Ward ARJO WIGGINS MEDICAL, INC. 962 ALLEGRO LANE Apollo Beach, FL 33572 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-24 |
| Decision Date | 2006-12-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00616784447230 | K062100 | 000 |
| 00815588021343 | K062100 | 000 |
| 00815588021367 | K062100 | 000 |
| 00815588021381 | K062100 | 000 |
| 00815588021398 | K062100 | 000 |
| 00815588021404 | K062100 | 000 |
| 00815588021428 | K062100 | 000 |
| 00815588021442 | K062100 | 000 |
| 00815588021466 | K062100 | 000 |
| 00815588021336 | K062100 | 000 |
| 00815588021329 | K062100 | 000 |
| 00815588021183 | K062100 | 000 |
| 00815588021206 | K062100 | 000 |
| 00815588021220 | K062100 | 000 |
| 00815588021244 | K062100 | 000 |
| 00815588021268 | K062100 | 000 |
| 00815588021282 | K062100 | 000 |
| 00815588021305 | K062100 | 000 |
| 00815588021312 | K062100 | 000 |
| 00815588021480 | K062100 | 000 |
| 00815588021503 | K062100 | 000 |
| 00616784442037 | K062100 | 000 |
| 00616784442433 | K062100 | 000 |
| 00616784443034 | K062100 | 000 |
| 00616784443638 | K062100 | 000 |
| 00616784444031 | K062100 | 000 |
| 00616784444536 | K062100 | 000 |
| 00616784444833 | K062100 | 000 |
| 00616784445434 | K062100 | 000 |
| 00616784441535 | K062100 | 000 |
| 00616784441238 | K062100 | 000 |
| 00815588021527 | K062100 | 000 |
| 00815588021541 | K062100 | 000 |
| 10732224730797 | K062100 | 000 |
| 10732224730803 | K062100 | 000 |
| 10732224730827 | K062100 | 000 |
| 10732224730834 | K062100 | 000 |
| 10732224733538 | K062100 | 000 |
| 10732224733583 | K062100 | 000 |
| 00815588021169 | K062100 | 000 |