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 |