The following data is part of a premarket notification filed by Mahe Intl., Inc. with the FDA for Mahe Pediatric Naso Pharyngoscope Its Associated And Ancillary Equipment And Endoscopic Accessories.
| Device ID | K030857 |
| 510k Number | K030857 |
| Device Name: | MAHE PEDIATRIC NASO PHARYNGOSCOPE ITS ASSOCIATED AND ANCILLARY EQUIPMENT AND ENDOSCOPIC ACCESSORIES |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | MAHE INTL., INC. 490 CRAIGHEAD Nashville, TN 37204 |
| Contact | Paul Cart |
| Correspondent | Paul Cart MAHE INTL., INC. 490 CRAIGHEAD Nashville, TN 37204 |
| Product Code | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-18 |
| Decision Date | 2003-10-16 |
| Summary: | summary |