The following data is part of a premarket notification filed by Kl Martin L.p. with the FDA for Kls Martin Electrosurgical Instruments.
Device ID | K082505 |
510k Number | K082505 |
Device Name: | KLS MARTIN ELECTROSURGICAL INSTRUMENTS |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | KL MARTIN L.P. 11239 ST. JOHNS INDUST. PKY S. Jacksonville, FL 32246 |
Contact | Tom Faucett |
Correspondent | Tom Faucett KL MARTIN L.P. 11239 ST. JOHNS INDUST. PKY S. Jacksonville, FL 32246 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-08-29 |
Decision Date | 2009-06-12 |
Summary: | summary |