The following data is part of a premarket notification filed by Parkell, Inc. with the FDA for Safe-t-pins Retentive Pin System.
Device ID | K760723 |
510k Number | K760723 |
Device Name: | SAFE-T-PINS RETENTIVE PIN SYSTEM |
Classification | Pin, Retentive And Splinting, And Accessory Instruments |
Applicant | PARKELL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EBL |
CFR Regulation Number | 872.3740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-09-27 |
Decision Date | 1976-10-21 |