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 |