The following data is part of a premarket notification filed by Pelton & Crane Co. with the FDA for Orthophos Plus And Orthophos Plus/cd.
| Device ID | K972249 |
| 510k Number | K972249 |
| Device Name: | ORTHOPHOS PLUS AND ORTHOPHOS PLUS/CD |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | PELTON & CRANE CO. 49 PLAIN ST. North Atteboro,, MA 02760 |
| Contact | Sheila Hemeon-heyer |
| Correspondent | Sheila Hemeon-heyer PELTON & CRANE CO. 49 PLAIN ST. North Atteboro,, MA 02760 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-16 |
| Decision Date | 1997-09-12 |
| Summary: | summary |