The following data is part of a premarket notification filed by Plastafil, Inc. with the FDA for Strover Hook.
Device ID | K841617 |
510k Number | K841617 |
Device Name: | STROVER HOOK |
Classification | Instrument, Ligature Passing And Knot Tying |
Applicant | PLASTAFIL, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | HCF |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-04-19 |
Decision Date | 1984-08-27 |