The following data is part of a premarket notification filed by Protectical Health & Safety Ltd. with the FDA for Respakit.
| Device ID | K892053 |
| 510k Number | K892053 |
| Device Name: | RESPAKIT |
| Classification | Airway, Oropharyngeal, Anesthesiology |
| Applicant | PROTECTICAL HEALTH & SAFETY LTD. ADVOCACY SERVICES GROUP 1825 EYE STREET N.W., STE 400 Washington, DC 20006 |
| Contact | Richard T Ney |
| Correspondent | Richard T Ney PROTECTICAL HEALTH & SAFETY LTD. ADVOCACY SERVICES GROUP 1825 EYE STREET N.W., STE 400 Washington, DC 20006 |
| Product Code | CAE |
| CFR Regulation Number | 868.5110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-29 |
| Decision Date | 1989-04-27 |