The following data is part of a premarket notification filed by Candace Lane Corp. with the FDA for Solcoseryl Tissue Culture Growth Supplement.
Device ID | K872847 |
510k Number | K872847 |
Device Name: | SOLCOSERYL TISSUE CULTURE GROWTH SUPPLEMENT |
Classification | Sera, Animal And Human |
Applicant | CANDACE LANE CORP. 140 LITTLETON RD. SUITE 301 Parsippany, NJ 07054 |
Contact | Wolfgang Jochle |
Correspondent | Wolfgang Jochle CANDACE LANE CORP. 140 LITTLETON RD. SUITE 301 Parsippany, NJ 07054 |
Product Code | KIS |
CFR Regulation Number | 864.2800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-07-20 |
Decision Date | 1987-08-10 |