The following data is part of a premarket notification filed by Med-plastics Intl., Inc. with the FDA for Hyper-inflation Bag.
| Device ID | K942571 |
| 510k Number | K942571 |
| Device Name: | HYPER-INFLATION BAG |
| Classification | Resuscitator, Manual, Non Self-inflating |
| Applicant | MED-PLASTICS INTL., INC. 5668 WEST 73RD. ST. Indianapolis, IN 46278 |
| Contact | Terry G Rosenkoetter |
| Correspondent | Terry G Rosenkoetter MED-PLASTICS INTL., INC. 5668 WEST 73RD. ST. Indianapolis, IN 46278 |
| Product Code | NHK |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-31 |
| Decision Date | 1994-06-10 |