The following data is part of a premarket notification filed by Wilo Medizintechnik Lothar Wilberg Gmbh with the FDA for Wilomat Sterilizable Clip Forceps W/interchangable Magazines.
Device ID | K954435 |
510k Number | K954435 |
Device Name: | WILOMAT STERILIZABLE CLIP FORCEPS W/INTERCHANGABLE MAGAZINES |
Classification | Clip, Implantable |
Applicant | WILO MEDIZINTECHNIK LOTHAR WILBERG GMBH 2550 M STREET, N.W. Washington, DC 20037 |
Contact | Mark Heller |
Correspondent | Mark Heller WILO MEDIZINTECHNIK LOTHAR WILBERG GMBH 2550 M STREET, N.W. Washington, DC 20037 |
Product Code | FZP |
CFR Regulation Number | 878.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-09-22 |
Decision Date | 1995-10-23 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10884521057500 | K954435 | 000 |
20884521057712 | K954435 | 000 |
10884521057708 | K954435 | 000 |
10884521057494 | K954435 | 000 |
10884521057487 | K954435 | 000 |