The following data is part of a premarket notification filed by Ceremed, Inc. with the FDA for Adaptain Fastwrap, Envelock, Graftain.
| Device ID | K122561 |
| 510k Number | K122561 |
| Device Name: | ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN |
| Classification | Polymer, Ent Synthetic-polyamide (mesh Or Foil Material) |
| Applicant | CEREMED, INC. 3643 LENAWEE AVE. Los Angeles, CA 90016 |
| Contact | Chelsea Mitchell |
| Correspondent | Chelsea Mitchell CEREMED, INC. 3643 LENAWEE AVE. Los Angeles, CA 90016 |
| Product Code | KHJ |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-22 |
| Decision Date | 2012-11-27 |
| Summary: | summary |