The following data is part of a premarket notification filed by F.m. Wiest Usa, Inc. with the FDA for Arthroflator.
Device ID | K865066 |
510k Number | K865066 |
Device Name: | ARTHROFLATOR |
Classification | Arthroscope |
Applicant | F.M. WIEST USA, INC. 1301 N. KINGS HIGHWAY Cherry Hill, NJ 08034 |
Contact | Wayne W Disanza |
Correspondent | Wayne W Disanza F.M. WIEST USA, INC. 1301 N. KINGS HIGHWAY Cherry Hill, NJ 08034 |
Product Code | HRX |
CFR Regulation Number | 888.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-12-24 |
Decision Date | 1987-04-20 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ARTHROFLATOR 75768867 not registered Dead/Abandoned |
KARL STORZ GmbH & Co 1999-08-03 |