STERI-LUB LUBRICATION GEL— 510(k) K083189
Substantially EquivalentAvail Medical Products, Inc.
FDA 510(k) clearance K083189 for STERI-LUB LUBRICATION GEL, Substantially Equivalent on 2008-11-21. Applicant: Avail Medical Products, Inc.. Device class: 1.
Clearance details
- Applicant
- Avail Medical Products, 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
- Special
- Location
- Santa Ana, CA, US
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