The following data is part of a premarket notification filed by Medspec Corp. with the FDA for Medspec Safety Pins.
Device ID | K800278 |
510k Number | K800278 |
Device Name: | MEDSPEC SAFETY PINS |
Classification | Drape, Surgical |
Applicant | MEDSPEC CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | KKX |
CFR Regulation Number | 878.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-02-05 |
Decision Date | 1980-05-02 |