MULTI-STRIP
FDA 510(k) clearance K901228 · decided 1990-05-07
Clearance details
- K-number
- K901228
- Device name
- MULTI-STRIP
- Applicant
- Bellhouse Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-03-14
- Decision date
- 1990-05-07
- Days to decision
- 54 days
- Clearance type
- Traditional
- Product code
- FKX
- Device class
- 2
- Regulation number
- 876.5630
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Lake Elmo, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.