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510(k) K962020

S-41 & S-41S VIDEO IMAGING SYSTEM by Del Medical Systems Corp. — Product Code GCJ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 30, 1996
Date Received: May 23, 1996
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Laparoscope, General & Plastic Surgery
Device Class: Class II
Regulation Number: 876.1500
Review Panel: SU
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).

Other clearances by Del Medical Systems Corp.

K962684 — S-357 VIDEO IMAGING SYSTEM (October 15, 1996)
K962651 — S-52 ELECTRONIC VIDEO LAPAROSCOPE (September 30, 1996)
K960301 — ND VISION-220 ADAPTIVE IMAGE PROCESSESSOR (September 30, 1996)
K962979 — S-53 INTRORAL DENTAL SYSTEM (September 25, 1996)
K962024 — S-57 VIDEO IMAGING SYSTEM (July 9, 1996)
K942924 — MSV-2000 VIDEO IMAGING SYSTEM (October 3, 1994)

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