The following data is part of a premarket notification filed by Simpson/basye, Inc. with the FDA for Hand Mirror (endoscope).
| Device ID | K862717 |
| 510k Number | K862717 |
| Device Name: | HAND MIRROR (ENDOSCOPE) |
| Classification | Endoscope, Mirror |
| Applicant | SIMPSON/BASYE, INC. 430 AYRE ST. Wilmington, DE 19804 |
| Contact | Robert Basye |
| Correspondent | Robert Basye SIMPSON/BASYE, INC. 430 AYRE ST. Wilmington, DE 19804 |
| Product Code | GCO |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-17 |
| Decision Date | 1986-07-30 |