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510(k) K801610

CHILDREN'S HOSPITAL PEDIATRIC RETRACTOR by Edward Weck, Inc. — Product Code GCZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 1980
Date Received
July 15, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Retainer, Surgical
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Edward Weck, Inc.

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  • K914470 — PNEUMO-SEAL(TM) (November 29, 1991)
  • K911272 — ENDOSCOPIC NEEDLHOLDER CAT. NUMBER 114705 (July 2, 1991)
  • K902108 — HEM-O-LOK(TM) (August 6, 1990)
  • K902232 — WECK ELECTROSURGICAL GENERATOR #174200 (August 2, 1990)
  • K897045 — BOWIE-DICK TEST CARD CATALOG NUMBER 008018 (February 15, 1990)
  • K871110 — CORONARY ARTERY BYPASS GRAFT (CABG) MARKER (August 27, 1987)
  • K851251 — AUTO/MANUAL TITANIUM HEMOCLIP LIGATING CLIP 527200 (July 2, 1985)

Other clearances for product code GCZ

  • K904536 — JAIN GRAFT ASSIST (November 29, 1990)
  • K893870 — ADAMS BREAST IMPLANT PROTECTOR (July 14, 1989)
  • K870809 — MCNEALY-GLASSMAN VISCERA RETAINER #3202/3204/3206 (March 19, 1987)
  • K802806 — VISECERA RETAINER (January 23, 1981)