The following data is part of a premarket notification filed by Suretek Medical with the FDA for Suretek Reprocessed Laparoscopic Instruments.
Device ID | K052690 |
510k Number | K052690 |
Device Name: | SURETEK REPROCESSED LAPAROSCOPIC INSTRUMENTS |
Classification | Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed |
Applicant | SURETEK MEDICAL 44 BELLWOOD FARMS Greenville, SC 29607 |
Contact | Mike Sammon |
Correspondent | Mike Sammon SURETEK MEDICAL 44 BELLWOOD FARMS Greenville, SC 29607 |
Product Code | NUJ |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-09-28 |
Decision Date | 2006-05-12 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B3907865001 | K052690 | 000 |
B3907845151 | K052690 | 000 |
B3907844151 | K052690 | 000 |
B3901766431 | K052690 | 000 |