The following data is part of a premarket notification filed by Biofilm, Inc. with the FDA for Glycerin & Paraben Free Astroglide.
Device ID | K072647 |
510k Number | K072647 |
Device Name: | GLYCERIN & PARABEN FREE ASTROGLIDE |
Classification | Lubricant, Personal |
Applicant | BIOFILM, INC. 3225 EXECUTIVE RIDGE Vista, CA 92081 |
Contact | Robert De Armond |
Correspondent | Robert De Armond BIOFILM, INC. 3225 EXECUTIVE RIDGE Vista, CA 92081 |
Product Code | NUC |
CFR Regulation Number | 884.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-09-19 |
Decision Date | 2008-01-25 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00015594011882 | K072647 | 000 |
00015594010632 | K072647 | 000 |
00015594011929 | K072647 | 000 |
00015594011776 | K072647 | 000 |