The following data is part of a premarket notification filed by Western Medical Products, Inc. with the FDA for Ticlip Sterial Disposable.
Device ID | K843589 |
510k Number | K843589 |
Device Name: | TICLIP STERIAL DISPOSABLE |
Classification | Clip, Implantable |
Applicant | WESTERN MEDICAL PRODUCTS, INC. Van Nuys , CA 91405 - |
Contact | Barry Pressman |
Correspondent | Barry Pressman WESTERN MEDICAL PRODUCTS, INC. Van Nuys , CA 91405 - |
Product Code | FZP |
CFR Regulation Number | 878.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-09-12 |
Decision Date | 1984-10-24 |