510(k) K935299
K935299 is an FDA 510(k) premarket notification submitted by Biofilm, Inc. for the device "ASTROGLIDE". The FDA issued a decision of Substantially Equivalent on February 18, 1994. The device falls under product code KMJ (Lubricant, Patient), a Class I device regulated under 21 CFR 880.6375. Biofilm, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 18, 1994
- Date Received
- November 2, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lubricant, Patient
- Device Class
- Class I
- Regulation Number
- 880.6375
- Review Panel
- HO
- Submission Type