AMEDA DISPOSABLE VACUUM ASSIST CUP WITH FLUID RETENTION TRAP
FDA 510(k) clearance K980976 · decided 1998-08-21
Clearance details
- K-number
- K980976
- Device name
- AMEDA DISPOSABLE VACUUM ASSIST CUP WITH FLUID RETENTION TRAP
- Applicant
- Hollister, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-03-16
- Decision date
- 1998-08-21
- Days to decision
- 158 days
- Clearance type
- Traditional
- Product code
- HDB
- Device class
- 2
- Regulation number
- 884.4340
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Libertyville, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.