The following data is part of a premarket notification filed by Cutter Laboratories, Inc. with the FDA for Cutter Points.
Device ID | K792250 |
510k Number | K792250 |
Device Name: | CUTTER POINTS |
Classification | Point, Abrasive |
Applicant | CUTTER LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EHL |
CFR Regulation Number | 872.6010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-11-08 |
Decision Date | 1980-01-23 |