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510(k) K802586

AMERICAN HEYER-SCHULTE LOW PROFILE VALVE by American Heyer Schulte — Product Code JXG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 1980
Date Received
October 20, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shunt, Central Nervous System And Components
Device Class
Class II
Regulation Number
882.5550
Review Panel
NE
Submission Type

Other clearances by American Heyer Schulte

  • K840172 — VENTRAL WALL DEFECT REDUCT SILO (June 27, 1984)
  • K834593 — ONE-PIECE SHUNT (April 3, 1984)
  • K833502 — RADOVAN SUBCUTANEOUS TISSUE EXPANDER (February 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)

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