The following data is part of a premarket notification filed by Interspec, Inc. with the FDA for Interspec Apogee Endo-v Probe And Needle Guide.
| Device ID | K915696 |
| 510k Number | K915696 |
| Device Name: | INTERSPEC APOGEE ENDO-V PROBE AND NEEDLE GUIDE |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | INTERSPEC, INC. 110 WEST BUTLER AVE. Ambler, PA 19002 |
| Contact | Arthur Schenck |
| Correspondent | Arthur Schenck INTERSPEC, INC. 110 WEST BUTLER AVE. Ambler, PA 19002 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-23 |
| Decision Date | 1992-11-24 |