The following data is part of a premarket notification filed by Premier Sundries, Inc. with the FDA for Visa-grip.
Device ID | K790191 |
510k Number | K790191 |
Device Name: | VISA-GRIP |
Classification | Exerciser, Non-measuring |
Applicant | PREMIER SUNDRIES, INC. MD |
Product Code | ION |
CFR Regulation Number | 890.5370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-01-26 |
Decision Date | 1979-02-08 |