ASTROGLIDE— 510(k) K935299
Substantially EquivalentBiofilm, Inc.
FDA 510(k) clearance K935299 for ASTROGLIDE, Substantially Equivalent on 1994-02-18. Applicant: Biofilm, Inc.. Device class: 1.
Clearance details
- Applicant
- Biofilm, Inc.
- Product code
- Code KMJ
- Device class
- Class 1
- Regulation
- 21 CFR 880.6375
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Vista, CA, US
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