The following data is part of a premarket notification filed by Biofilm Inc. with the FDA for Astroglide O Oil Personal Lubricant & Massage Oil.
Device ID | K171985 |
510k Number | K171985 |
Device Name: | Astroglide O Oil Personal Lubricant & Massage Oil |
Classification | Lubricant, Personal |
Applicant | BioFilm Inc. 3225 Executive Ridge Vista, CA 92081 |
Contact | Richard Hines |
Correspondent | Richard Hines 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 | 2017-07-03 |
Decision Date | 2017-08-30 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00015594011417 | K171985 | 000 |
00015594011738 | K171985 | 000 |
00015594011844 | K171985 | 000 |