SISS, INC. (D.B.A.MEDISISS) REPROCESSD ELECTROSURGICAL INSTRUMENTS AND ACCESSORIES
FDA 510(k) clearance K030919 · decided 2003-07-03
Clearance details
- K-number
- K030919
- Device name
- SISS, INC. (D.B.A.MEDISISS) REPROCESSD ELECTROSURGICAL INSTRUMENTS AND ACCESSORIES
- Applicant
- Medisiss
- Decision
- Substantially Equivalent
- Date received
- 2003-03-24
- Decision date
- 2003-07-03
- Days to decision
- 101 days
- Clearance type
- Traditional
- Product code
- NLR
- Device class
- 2
- Regulation number
- 876.4300
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Sisters, OR, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.