RUSCH SIMPLASTIC FOLEY CATHETERIZATION SET
FDA 510(k) clearance K963993 · decided 1996-12-17
Clearance details
- K-number
- K963993
- Device name
- RUSCH SIMPLASTIC FOLEY CATHETERIZATION SET
- Applicant
- Rusch, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-10-04
- Decision date
- 1996-12-17
- Days to decision
- 74 days
- Clearance type
- Traditional
- Product code
- FCM
- Device class
- 2
- Regulation number
- 876.5130
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Jeffrey, NH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.