The following data is part of a premarket notification filed by Tecnol New Jersey Wound Care, Inc. with the FDA for Tecnol Stirrups Strap.
Device ID | K791859 |
510k Number | K791859 |
Device Name: | TECNOL STIRRUPS STRAP |
Classification | Table And Attachments, Operating-room |
Applicant | TECNOL NEW JERSEY WOUND CARE, INC. 368 FAIRVIEW AVE. Hammonton, NJ 08037 -0268 |
Product Code | BWN |
CFR Regulation Number | 878.4950 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-09-18 |
Decision Date | 1979-10-04 |