The following data is part of a premarket notification filed by Encoll Corp. with the FDA for Healicoll.
| Device ID | K040314 |
| 510k Number | K040314 |
| Device Name: | HEALICOLL |
| Classification | Dressing, Wound, Collagen |
| Applicant | ENCOLL CORP. 5686 GERANIUM CT. Newark, CA 94560 |
| Contact | Subramanian Gunasekaran |
| Correspondent | Subramanian Gunasekaran ENCOLL CORP. 5686 GERANIUM CT. Newark, CA 94560 |
| Product Code | KGN |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-09 |
| Decision Date | 2004-08-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860000744447 | K040314 | 000 |
| 00860000744430 | K040314 | 000 |
| 00860000744423 | K040314 | 000 |
| 00860000744416 | K040314 | 000 |
| 00860000744409 | K040314 | 000 |
| 00860000744485 | K040314 | 000 |
| 00860000744478 | K040314 | 000 |
| 00860000744461 | K040314 | 000 |
| 00860000744454 | K040314 | 000 |