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 |