The following data is part of a premarket notification filed by National Biological Corp. with the FDA for Handisol.
Device ID | K924077 |
510k Number | K924077 |
Device Name: | HANDISOL |
Classification | Light, Ultraviolet, Dermatological |
Applicant | NATIONAL BIOLOGICAL CORP. 1532 ENTERPRISE PKWY. Twinsburg, OH 44087 |
Contact | Arthur S Goddard |
Correspondent | Arthur S Goddard NATIONAL BIOLOGICAL CORP. 1532 ENTERPRISE PKWY. Twinsburg, OH 44087 |
Product Code | FTC |
CFR Regulation Number | 878.4630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-08-12 |
Decision Date | 1992-11-20 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00816878020190 | K924077 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
HANDISOL 74473858 1865704 Live/Registered |
National Biological Corporation 1993-12-27 |
HANDISOL 72443906 0970964 Dead/Expired |
CONSOLIDATED FOODS CORPORATION 1972-12-15 |