The following data is part of a premarket notification filed by National Biological Corp. with the FDA for Panosol 2000 624-414.
Device ID | K872651 |
510k Number | K872651 |
Device Name: | PANOSOL 2000 624-414 |
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 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00816878020886 | K872651 | 000 |
00816878020299 | K872651 | 000 |
00816878020039 | K872651 | 000 |
00816878020022 | K872651 | 000 |