The following data is part of a premarket notification filed by Biofilm, Inc. with the FDA for Astroglide Ttc Fertility Friendly Personal Lubricant.
Device ID | K141132 |
510k Number | K141132 |
Device Name: | ASTROGLIDE TTC FERTILITY FRIENDLY PERSONAL LUBRICANT |
Classification | Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible |
Applicant | BIOFILM, INC. 3225 Executive Rdg Vista, CA 92081 |
Contact | Sherry Castello |
Correspondent | Sherry Castello BIOFILM, INC. 3225 Executive Rdg Vista, CA 92081 |
Product Code | PEB |
CFR Regulation Number | 884.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-05-01 |
Decision Date | 2015-01-09 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00015594011226 | K141132 | 000 |