510(k) K030919
- Device
- SISS, INC. (D.B.A.MEDISISS) REPROCESSD ELECTROSURGICAL INSTRUMENTS AND ACCESSORIES
- Applicant
- MEDISISS
- 510(k) number
- K030919
- Product code
- NLR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-07-03
- Date received
- 2003-03-24
- Regulation
- 876.4300
- Classification name
- Unit, Electrosurgical, Endoscopic (with Or Without Accessories), Reprocessed
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- Yes
Applicant Contact#
- Contact
- MRRY ANN BARKER
- Address
- 723 Curtis Ct. P.O. Box 2060 Sisters OR US 97759 97759
Source Documents#
Legacy Summary#
summary
FDA Review#
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