The following data is part of a premarket notification filed by Alberto-culver Usa, Inc. with the FDA for Fds Intimate And Intimate Warming Lubricant.
Device ID | K060145 |
510k Number | K060145 |
Device Name: | FDS INTIMATE AND INTIMATE WARMING LUBRICANT |
Classification | Lubricant, Personal |
Applicant | ALBERTO-CULVER USA, INC. 2525 WEST ARMITAGE AVE. Melrose Park, IL 60148 |
Contact | Rick Main |
Correspondent | Rick Main ALBERTO-CULVER USA, INC. 2525 WEST ARMITAGE AVE. Melrose Park, IL 60148 |
Product Code | NUC |
CFR Regulation Number | 884.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | Yes |
Date Received | 2006-01-19 |
Decision Date | 2006-04-14 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
1031191718961 | K060145 | 000 |
10311917189595 | K060145 | 000 |
10311917187041 | K060145 | 000 |