The following data is part of a premarket notification filed by Walter Lorenz Surgical, Inc. with the FDA for Rapidflap Cranial Clamp.
| Device ID | K991029 |
| 510k Number | K991029 |
| Device Name: | RAPIDFLAP CRANIAL CLAMP |
| Classification | Plate, Cranioplasty, Preformed, Non-alterable |
| Applicant | WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DR. Jacksonville, FL 32218 |
| Contact | Diana Preston |
| Correspondent | Diana Preston WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DR. Jacksonville, FL 32218 |
| Product Code | GXN |
| CFR Regulation Number | 882.5330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-29 |
| Decision Date | 1999-04-23 |
| Summary: | summary |