The following data is part of a premarket notification filed by Cher Mel Corp. with the FDA for Chermel Scalp Vein Set.
| Device ID | K851516 |
| 510k Number | K851516 |
| Device Name: | CHERMEL SCALP VEIN SET |
| Classification | Set, Administration, Intravascular |
| Applicant | CHER MEL CORP. P.O. BOX 68624 Seattle, WA 98168 |
| Contact | Cheryl Amundsen |
| Correspondent | Cheryl Amundsen CHER MEL CORP. P.O. BOX 68624 Seattle, WA 98168 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-15 |
| Decision Date | 1985-08-23 |