The following data is part of a premarket notification filed by Pilling Weck, Inc. with the FDA for Pilling Weck M-20 Disposable Automatic Hemoclip.
Device ID | K944552 |
510k Number | K944552 |
Device Name: | PILLING WECK M-20 DISPOSABLE AUTOMATIC HEMOCLIP |
Classification | Clip, Implantable |
Applicant | PILLING WECK, INC. 1 WECK DR. Research Triangle Park, NC 27709 |
Contact | Ponzelle Royster |
Correspondent | Ponzelle Royster PILLING WECK, INC. 1 WECK DR. Research Triangle Park, NC 27709 |
Product Code | FZP |
CFR Regulation Number | 878.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-09-16 |
Decision Date | 1994-11-07 |