The following data is part of a premarket notification filed by Vista Medical Products, Inc. with the FDA for Weck Microsurgical Knife.
Device ID | K791286 |
510k Number | K791286 |
Device Name: | WECK MICROSURGICAL KNIFE |
Classification | Knife, Surgical |
Applicant | VISTA MEDICAL PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EMF |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-07-09 |
Decision Date | 1979-07-24 |