510(k) K936280

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

July 12, 1994

Date Received

October 1, 1993

Clearance Type

Traditional

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Arthroscope

Device Class

Class II

Regulation Number

888.1100

Review Panel

OR

Submission Type

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).