DISPOSABLE AMNIOTOME
FDA 510(k) clearance K883283 · decided 1988-10-18
Clearance details
- K-number
- K883283
- Device name
- DISPOSABLE AMNIOTOME
- Applicant
- Galenica Enterprises, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-08-04
- Decision date
- 1988-10-18
- Days to decision
- 75 days
- Clearance type
- Traditional
- Product code
- HGG
- Device class
- 2
- Regulation number
- 884.5070
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Quebec Canada J7e 4h7, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.