HOC SET WITH VALVE, HOC SET WITHOUT VALVE, HOC SET WITH VALVE - SOFT PLUG, HOC SET WITHOUT VALVE - SOFT PLUG, OPS WITHOU
FDA 510(k) clearance K990913 · decided 1999-06-08
Clearance details
- K-number
- K990913
- Device name
- HOC SET WITH VALVE, HOC SET WITHOUT VALVE, HOC SET WITH VALVE - SOFT PLUG, HOC SET WITHOUT VALVE - SOFT PLUG, OPS WITHOU
- Applicant
- Laboratoires Prodimed
- Decision
- Substantially Equivalent
- Date received
- 1999-03-18
- Decision date
- 1999-06-08
- Days to decision
- 82 days
- Clearance type
- Traditional
- Product code
- MQE
- Device class
- 2
- Regulation number
- 884.6100
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Ringoes, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.