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 |