The following data is part of a premarket notification filed by Medisiss with the FDA for Siss, Inc. (d.b.a.medisiss) Reprocessd Electrosurgical Instruments And Accessories.
Device ID | K030919 |
510k Number | K030919 |
Device Name: | SISS, INC. (D.B.A.MEDISISS) REPROCESSD ELECTROSURGICAL INSTRUMENTS AND ACCESSORIES |
Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories), Reprocessed |
Applicant | MEDISISS 723 CURTIS COURT PO BOX 2060 Sisters, OR 97759 |
Contact | Mrry Ann Barker |
Product Code | NLR |
CFR Regulation Number | 876.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2003-03-24 |
Decision Date | 2003-07-03 |
Summary: | summary |