The following data is part of a premarket notification filed by Plastic Parts Corp. with the FDA for Goettinger Emergency Resuscitation Tube.
| Device ID | K892123 |
| 510k Number | K892123 |
| Device Name: | GOETTINGER EMERGENCY RESUSCITATION TUBE |
| Classification | Airway, Oropharyngeal, Anesthesiology |
| Applicant | PLASTIC PARTS CORP. 213 ROYAL PALM DR. Fort Lauderdale, FL 33301 |
| Contact | Olaf Mittelstaedt |
| Correspondent | Olaf Mittelstaedt PLASTIC PARTS CORP. 213 ROYAL PALM DR. Fort Lauderdale, FL 33301 |
| Product Code | CAE |
| CFR Regulation Number | 868.5110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-03 |
| Decision Date | 1989-07-14 |