The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Scalpfix Clip System.
| Device ID | K012219 |
| 510k Number | K012219 |
| Device Name: | SCALPFIX CLIP SYSTEM |
| Classification | Clip, Scalp |
| Applicant | AESCULAP, INC. 3773 Corporate Parkway Center Valley, PA 18034 |
| Contact | Lisa M Millington |
| Correspondent | Lisa M Millington AESCULAP, INC. 3773 Corporate Parkway Center Valley, PA 18034 |
| Product Code | HBO |
| CFR Regulation Number | 882.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-16 |
| Decision Date | 2001-07-31 |
| Summary: | summary |