510(k) K953888
K953888 is an FDA 510(k) premarket notification submitted by Vista Medical Technologies, Inc. for the device "TELESCOPE 4MM, 2.7MM DIAM. WIDE ANGLE 0', 30', 70', 4MM, DIAM, 30' WORK, L 14CM, AUTOCLAVABLE". The FDA issued a decision of Substantially Equivalent on October 7, 1995. The device falls under product code EOB (Nasopharyngoscope (Flexible Or Rigid)), a Class II device regulated under 21 CFR 874.4760. Vista Medical Technologies, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 7, 1995
- Date Received
- August 17, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Nasopharyngoscope (Flexible Or Rigid)
- Device Class
- Class II
- Regulation Number
- 874.4760
- Review Panel
- EN
- Submission Type
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).