The following data is part of a premarket notification filed by Intec Medical, Inc. with the FDA for Disposable Heated Wire Loops 48 And 72.
Device ID | K860941 |
510k Number | K860941 |
Device Name: | DISPOSABLE HEATED WIRE LOOPS 48 AND 72 |
Classification | Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer |
Applicant | INTEC MEDICAL, INC. 22200 E. 40 HWY Blue Springs, MO 64015 |
Contact | J. W Brown |
Correspondent | J. W Brown INTEC MEDICAL, INC. 22200 E. 40 HWY Blue Springs, MO 64015 |
Product Code | BZE |
CFR Regulation Number | 868.5270 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-03-12 |
Decision Date | 1986-04-02 |