The following data is part of a premarket notification filed by Biofilm, Inc. with the FDA for Astroglide Brand Warming Liquid Personal Lubricant.
Device ID | K041432 |
510k Number | K041432 |
Device Name: | ASTROGLIDE BRAND WARMING LIQUID PERSONAL LUBRICANT |
Classification | Condom |
Applicant | BIOFILM, INC. 3225 EXECUTIVE RIDGE Vista, CA 92081 |
Contact | Robert L De Armond |
Correspondent | Robert L De Armond BIOFILM, INC. 3225 EXECUTIVE RIDGE Vista, CA 92081 |
Product Code | HIS |
CFR Regulation Number | 884.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-05-28 |
Decision Date | 2004-11-30 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00015594010342 | K041432 | 000 |
00015594011967 | K041432 | 000 |