The following data is part of a premarket notification filed by Mectra Labs, Inc. with the FDA for Tubalgator.
| Device ID | K113080 |
| 510k Number | K113080 |
| Device Name: | TUBALGATOR |
| Classification | Coagulator-cutter, Endoscopic, Bipolar (and Accessories) |
| Applicant | MECTRA LABS, INC. TWO QUALITY WAY Bloomfield, IN 47424 |
| Contact | Charles E Allgood |
| Correspondent | Charles E Allgood MECTRA LABS, INC. TWO QUALITY WAY Bloomfield, IN 47424 |
| Product Code | HIN |
| CFR Regulation Number | 884.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-18 |
| Decision Date | 2012-06-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10817984010911 | K113080 | 000 |
| 10817984010904 | K113080 | 000 |