The following data is part of a premarket notification filed by Ad-tech Medical Instrument Corp. with the FDA for Ad-tech's Raab Infant Nasopharyngeal Prongs.
| Device ID | K940320 |
| 510k Number | K940320 |
| Device Name: | AD-TECH'S RAAB INFANT NASOPHARYNGEAL PRONGS |
| Classification | Airway, Nasopharyngeal |
| Applicant | AD-TECH MEDICAL INSTRUMENT CORP. 1901 WILLIAM ST. Racine, WI 53404 -1876 |
| Contact | David Anthony Putz |
| Correspondent | David Anthony Putz AD-TECH MEDICAL INSTRUMENT CORP. 1901 WILLIAM ST. Racine, WI 53404 -1876 |
| Product Code | BTQ |
| CFR Regulation Number | 868.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-24 |
| Decision Date | 1995-09-19 |