The following data is part of a premarket notification filed by Modern Medical Equipment Mfg., Ltd. with the FDA for Surgical Medical Device Cautery.
Device ID | K023506 |
510k Number | K023506 |
Device Name: | SURGICAL MEDICAL DEVICE CAUTERY |
Classification | Unit, Cautery, Thermal, Battery-powered |
Applicant | MODERN MEDICAL EQUIPMENT MFG., LTD. 1705 DABNEY RD. Richmond, VA 23230 |
Contact | Roger Strube |
Correspondent | Roger Strube MODERN MEDICAL EQUIPMENT MFG., LTD. 1705 DABNEY RD. Richmond, VA 23230 |
Product Code | HQP |
CFR Regulation Number | 886.4115 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-10-18 |
Decision Date | 2004-01-13 |