PURECEPTION LOWER PHASE, PURECEPTION UPPER PHASE, PURECEPTION WITH HEPES-BUFFERED HAM'S F-10 AND HSA— 510(k) K991381
Substantially EquivalentPacific Andrology, Inc.
FDA 510(k) clearance K991381 for PURECEPTION LOWER PHASE, PURECEPTION UPPER PHASE, PURECEPTION WITH HEPES-BUFFERED HAM'S F-10 AND HSA, Substantially Equivalent on 1999-09-24. Applicant: Pacific Andrology, Inc.. Device class: 2.
Clearance details
- Applicant
- Pacific Andrology, Inc.
- Product code
- Code MQL
- Device class
- Class 2
- Regulation
- 21 CFR 884.6180
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Recent devices under product code MQL
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