The following data is part of a premarket notification filed by Phillips Pharmaceuticals, Inc. with the FDA for Barrier Bone Wax Applicator.
Device ID | K934260 |
510k Number | K934260 |
Device Name: | BARRIER BONE WAX APPLICATOR |
Classification | Orthopedic Manual Surgical Instrument |
Applicant | PHILLIPS PHARMACEUTICALS, INC. 710 E. OGDEN AVE. SUITE 207 Naperville, IL 60563 |
Contact | A.g. Phillips |
Correspondent | A.g. Phillips PHILLIPS PHARMACEUTICALS, INC. 710 E. OGDEN AVE. SUITE 207 Naperville, IL 60563 |
Product Code | LXH |
CFR Regulation Number | 888.4540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-08-31 |
Decision Date | 1994-01-26 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
BARRIER BONE WAX APPLICATOR 75506610 2376571 Dead/Cancelled |
Phillips, Arnold G. 1998-06-22 |