The following data is part of a premarket notification filed by The Anspach Effort, Inc. with the FDA for Anspach Access Cranial Perforator.
| Device ID | K982991 |
| 510k Number | K982991 |
| Device Name: | ANSPACH ACCESS CRANIAL PERFORATOR |
| Classification | Drills, Burrs, Trephines & Accessories (compound, Powered) |
| Applicant | THE ANSPACH EFFORT, INC. 4500 RIVERSIDE DR. Palm Beach Gardens, FL 33410 |
| Contact | Lisa Kreider |
| Correspondent | Lisa Kreider THE ANSPACH EFFORT, INC. 4500 RIVERSIDE DR. Palm Beach Gardens, FL 33410 |
| Product Code | HBF |
| CFR Regulation Number | 882.4305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-27 |
| Decision Date | 1998-10-21 |