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510(k) K780247

IMPCO DISPOSABLE AORTIC PUNCH by Thoratec Laboratories Corp. — Product Code DWS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 1978
Date Received
February 13, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instruments, Surgical, Cardiovascular
Device Class
Class I
Regulation Number
870.4500
Review Panel
CV
Submission Type

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  • K823287 — RESPIRATORY CIRCUIT ADAPTOR (December 9, 1982)
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  • K934727 — REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELER (January 10, 1994)
  • K900379 — HYCULT DIAMOND CORONARY BYPASS KNIFE (March 19, 1990)
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