HYPOTRANS MODEL 750
FDA 510(k) clearance K911577 · decided 1992-07-08
Clearance details
- K-number
- K911577
- Device name
- HYPOTRANS MODEL 750
- Applicant
- Martin Mclane Medical
- Decision
- Substantially Equivalent
- Date received
- 1991-04-08
- Decision date
- 1992-07-08
- Days to decision
- 457 days
- Clearance type
- Traditional
- Product code
- KDK
- Device class
- 2
- Regulation number
- 876.5880
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- La Mesa, CA, US
- Third-party review
- No
- Expedited review
- No
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| RM3 RENAL PRESERVATION SYSTEM (K053169) | Waters Instruments, Inc. | 2006-01-17 |
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Recalls involving this device
No recalls on record reference this clearance.