The following data is part of a premarket notification filed by Spectrum Surgical Supply Corp. with the FDA for Insulation Tester.
| Device ID | K120416 |
| 510k Number | K120416 |
| Device Name: | INSULATION TESTER |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | SPECTRUM SURGICAL SUPPLY CORP. 4575 HUDSON DR. Stow, OH 44224 |
| Contact | Dennis A Kovit |
| Correspondent | Dennis A Kovit SPECTRUM SURGICAL SUPPLY CORP. 4575 HUDSON DR. Stow, OH 44224 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-10 |
| Decision Date | 2012-03-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00724995151850 | K120416 | 000 |