ASTROGLIDE

Lubricant, Patient

BIOFILM, INC.

The following data is part of a premarket notification filed by Biofilm, Inc. with the FDA for Astroglide.

Pre-market Notification Details

• Device ID: K935299
• 510k Number: K935299
• Device Name: ASTROGLIDE
• Classification: Lubricant, Patient
• Applicant: BIOFILM, INC. 3121 SCOTT ST. Vista, CA 92083
• Contact: Daniel X Wray
• Correspondent: Daniel X Wray; BIOFILM, INC. 3121 SCOTT ST. Vista, CA 92083
• Product Code: KMJ
• CFR Regulation Number: 880.6375 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1993-11-02
• Decision Date: 1994-02-18
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00813356000118	K935299	000