The following data is part of a premarket notification filed by National Biological Corp. with the FDA for Handisol Wound Healing.
| Device ID | K982082 |
| 510k Number | K982082 |
| Device Name: | HANDISOL WOUND HEALING |
| Classification | Light, Ultraviolet, Dermatological |
| Applicant | NATIONAL BIOLOGICAL CORP. 1532 ENTERPRISE PKWY. Twinsburg, OH 44087 |
| Contact | Francis D Lamm |
| Correspondent | Francis D Lamm 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 | 1998-06-15 |
| Decision Date | 1998-10-28 |
| Summary: | summary |