The following data is part of a premarket notification filed by Corin U.s.a. with the FDA for Endospot.
| Device ID | K963043 |
| 510k Number | K963043 |
| Device Name: | ENDOSPOT |
| Classification | Light Source, Fiberoptic, Routine |
| Applicant | CORIN U.S.A. 10500 UNIVERSITY CENTER DR., SUITE 190 Tampa, FL 33612 |
| Contact | Jack Thomas |
| Correspondent | Jack Thomas CORIN U.S.A. 10500 UNIVERSITY CENTER DR., SUITE 190 Tampa, FL 33612 |
| Product Code | FCW |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-05 |
| Decision Date | 1996-09-20 |
| Summary: | summary |