The following data is part of a premarket notification filed by National Biological Corp. with the FDA for Hand/foot Uva/uvb 624-224.
Device ID | K872649 |
510k Number | K872649 |
Device Name: | HAND/FOOT UVA/UVB 624-224 |
Classification | Light, Ultraviolet, Dermatological |
Applicant | NATIONAL BIOLOGICAL CORP. 1532 ENTERPRISE PKWY. Twinsburg, OH 44087 |
Contact | Arthur Goddard |
Correspondent | Arthur 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 | 1987-07-07 |
Decision Date | 1987-07-27 |