The following data is part of a premarket notification filed by Dm Medical Inc. with the FDA for Smoke Evacuation Hoses/tubing.
Device ID | K020510 |
510k Number | K020510 |
Device Name: | SMOKE EVACUATION HOSES/TUBING |
Classification | Apparatus, Exhaust, Surgical |
Applicant | DM MEDICAL INC. 10865 MILLINGTON CT. Cincinnati, OH 45242 |
Contact | Robert W Mays |
Correspondent | Robert W Mays DM MEDICAL INC. 10865 MILLINGTON CT. Cincinnati, OH 45242 |
Product Code | FYD |
CFR Regulation Number | 878.5070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-02-15 |
Decision Date | 2002-05-03 |
Summary: | summary |