The following data is part of a premarket notification filed by National Biological Corp. with the FDA for Phototherapy Timer.
Device ID | K924969 |
510k Number | K924969 |
Device Name: | PHOTOTHERAPY TIMER |
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 | 1992-09-30 |
Decision Date | 1993-02-23 |