The following data is part of a premarket notification filed by National Biological Corp. with the FDA for Houva Ii Uva.
Device ID | K885025 |
510k Number | K885025 |
Device Name: | HOUVA II UVA |
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 | 1988-12-05 |
Decision Date | 1989-01-09 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00816878020541 | K885025 | 000 |
00810182930695 | K885025 | 000 |