The following data is part of a premarket notification filed by Vista Medical Technologies, Inc. with the FDA for Telescope 4mm, 2.7mm Diam. Wide Angle 0', 30', 70', 4mm, Diam, 30' Work, L 14cm, Autoclavable.
| Device ID | K953888 |
| 510k Number | K953888 |
| Device Name: | TELESCOPE 4MM, 2.7MM DIAM. WIDE ANGLE 0', 30', 70', 4MM, DIAM, 30' WORK, L 14CM, AUTOCLAVABLE |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | VISTA MEDICAL TECHNOLOGIES, INC. 725 SOUTHGATE COURT Oceanside, CA 92057 |
| Contact | Kent Richards |
| Correspondent | Kent Richards VISTA MEDICAL TECHNOLOGIES, INC. 725 SOUTHGATE COURT Oceanside, CA 92057 |
| Product Code | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-17 |
| Decision Date | 1995-10-07 |