The following data is part of a premarket notification filed by Pmt Corp. with the FDA for Electrocautery System Model 1980.
Device ID | K933079 |
510k Number | K933079 |
Device Name: | ELECTROCAUTERY SYSTEM MODEL 1980 |
Classification | Unit, Cautery, Thermal, Battery-powered |
Applicant | PMT CORP. 1500 PARK RD. Chanhassen, MN 55317 |
Contact | David Costello |
Correspondent | David Costello PMT CORP. 1500 PARK RD. Chanhassen, MN 55317 |
Product Code | HQP |
CFR Regulation Number | 886.4115 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-06-23 |
Decision Date | 1994-02-22 |