The following data is part of a premarket notification filed by American Safety Razor Co. with the FDA for Personna Disposable Scalpel.
Device ID | K873142 |
510k Number | K873142 |
Device Name: | PERSONNA DISPOSABLE SCALPEL |
Classification | Blade, Scalpel |
Applicant | AMERICAN SAFETY RAZOR CO. P.O. BOX 500 Staunton, VA 24401 |
Contact | Jane O Sawyer |
Correspondent | Jane O Sawyer AMERICAN SAFETY RAZOR CO. P.O. BOX 500 Staunton, VA 24401 |
Product Code | GES |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-08-10 |
Decision Date | 1987-09-04 |