THE STRIPPER
FDA 510(k) clearance K993699 · decided 2000-05-16
Clearance details
- K-number
- K993699
- Device name
- THE STRIPPER
- Applicant
- Mid-Atlantic Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-11-02
- Decision date
- 2000-05-16
- Days to decision
- 196 days
- Clearance type
- Traditional
- Product code
- MQH
- Device class
- 2
- Regulation number
- 884.6130
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Medford, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.