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510(k) K872230

MODEL 366-29 ADAPTAID(TM) ADAPTER SLEEVE by Intermedics, Inc. — Product Code DBT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 1987
Date Received
June 9, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Factor Xiii A, S, Antigen, Antiserum, Control
Device Class
Class I
Regulation Number
866.5330
Review Panel
HE
Submission Type

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  • K933278 — INTERMEDICS TRIANGLE CHEST PROBE MODEL 526-04 (March 15, 1995)
  • K922042 — CARDIFIX ENDOCARDIAL PACING LEAD (April 29, 1993)
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