THE STRIPPER PGD
FDA 510(k) clearance K041435 · decided 2004-09-29
Clearance details
- K-number
- K041435
- Device name
- THE STRIPPER PGD
- Applicant
- Mid-Atlantic Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-05-28
- Decision date
- 2004-09-29
- Days to decision
- 124 days
- Clearance type
- Traditional
- Product code
- MQH
- Device class
- 2
- Regulation number
- 884.6130
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Marlton, 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.