The following data is part of a premarket notification filed by Surgical Instruments Service And Savings, Inc. with the FDA for Siss Inc. (d.b.a. Medisiss) Reprocessed Electrosurgical Instruments And Accessories.
Device ID | K031869 |
510k Number | K031869 |
Device Name: | SISS INC. (D.B.A. MEDISISS) REPROCESSED ELECTROSURGICAL INSTRUMENTS AND ACCESSORIES |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | SURGICAL INSTRUMENTS SERVICE AND SAVINGS, INC. 723 CURTIS CT, SUITE A Sisters, OR 97759 |
Contact | Mary Ann Barker |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2003-06-17 |
Decision Date | 2003-12-24 |
Summary: | summary |