HYSTEROMAT(TM) 3700
FDA 510(k) clearance K921871 · decided 1994-12-15
Clearance details
- K-number
- K921871
- Device name
- HYSTEROMAT(TM) 3700
- Applicant
- F.M. Wiest USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-04-20
- Decision date
- 1994-12-15
- Days to decision
- 969 days
- Clearance type
- Traditional
- Product code
- HIG
- Device class
- 2
- Regulation number
- 884.1700
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Oradell, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.