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510(k) K833502

RADOVAN SUBCUTANEOUS TISSUE EXPANDER by American Heyer Schulte — Product Code LCJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 1984
Date Received
October 5, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tissue Expander And Accessories
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by American Heyer Schulte

  • K840172 — VENTRAL WALL DEFECT REDUCT SILO (June 27, 1984)
  • K834593 — ONE-PIECE SHUNT (April 3, 1984)
  • K833698 — AMER. V. MUELLER SURG. STAPLES ILA (January 25, 1984)
  • K833704 — AMER. V. MUELLER SURGICALSTAPLES-CARTR (December 29, 1983)
  • K832738 — HEYER-SCHULTE AFTERLOADING CATHETER (September 29, 1983)
  • K823790 — VENTRICULAR ACCESS SYSTEM (April 28, 1983)
  • K822096 — CHEMOTHERAPY INFUSION CATHETER (April 12, 1983)
  • K822032 — LARGE VOLUME CLOSED WOUND SUCTION DRAIN (August 16, 1982)
  • K820247 — EXTERNAL VENTRICULAR DRAINAGE SYS. (February 18, 1982)
  • K811288 — SPETZLER LUMBAR-PERITONEAL SYSTEM (June 26, 1981)

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