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 |