ANSPACH MICROMAX SYSTEM
FDA 510(k) clearance K965080 · decided 1997-01-10
Clearance details
- K-number
- K965080
- Device name
- ANSPACH MICROMAX SYSTEM
- Applicant
- The Anspach Effort, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-12-19
- Decision date
- 1997-01-10
- Days to decision
- 22 days
- Clearance type
- Traditional
- Product code
- ERL
- Device class
- 2
- Regulation number
- 874.4250
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Palm Beach Gardens, FL, US
- Third-party review
- No
- Expedited review
- No
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