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510(k) K914922

UNISURGE TISSUE COLLECTION SYSTEM FOR ENDOS SURG by Charles L. Rose and Co., Inc. — Product Code GCJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 1992
Date Received
November 4, 1991
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 Charles L. Rose and Co., Inc.

  • K913244 — KTP/532 & KTP/YAG SURGICAL LASERS (July 28, 1992)
  • K904248 — MODEL GLASE 210 HOLMIUM LASER SYSTEM (December 14, 1990)
  • K903849 — MODEL RD-1200 RUBY LASER SYSTEM (September 5, 1990)

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