The following data is part of a premarket notification filed by Surgical Instruments Service And Savings, Inc. with the FDA for Medisiss Reprocessed Ultrasonic Instruments.
Device ID | K124033 |
510k Number | K124033 |
Device Name: | MEDISISS REPROCESSED ULTRASONIC INSTRUMENTS |
Classification | Scalpel, Ultrasonic, Reprocessed |
Applicant | SURGICAL INSTRUMENTS SERVICE AND SAVINGS, INC. 2747 SW 6TH STREET Redmond, OR 97756 |
Contact | Brandi J Panteleon |
Correspondent | Brandi J Panteleon SURGICAL INSTRUMENTS SERVICE AND SAVINGS, INC. 2747 SW 6TH STREET Redmond, OR 97756 |
Product Code | NLQ |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-12-28 |
Decision Date | 2014-01-07 |
Summary: | summary |