The following data is part of a premarket notification filed by Intertech Resources, Inc. with the FDA for Intertech Newborn Hyperinflation Bag System.
| Device ID | K894612 |
| 510k Number | K894612 |
| Device Name: | INTERTECH NEWBORN HYPERINFLATION BAG SYSTEM |
| Classification | Resuscitator, Manual, Non Self-inflating |
| Applicant | INTERTECH RESOURCES, INC. 5100 TICE ST. Ft. Myers, FL 33905 |
| Contact | James W Pope |
| Correspondent | James W Pope INTERTECH RESOURCES, INC. 5100 TICE ST. Ft. Myers, FL 33905 |
| Product Code | NHK |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-20 |
| Decision Date | 1989-09-08 |