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510(k) K942725

CMI VELVET TOUCH VACUUM EXTRACTOR by Columbia Medical & Surgical, Inc. — Product Code HDB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 1995
Date Received
June 9, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Extractor, Vacuum, Fetal
Device Class
Class II
Regulation Number
884.4340
Review Panel
OB
Submission Type

Other clearances by Columbia Medical & Surgical, Inc.

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  • K914552 — CMI VACUUM PUMP (September 7, 1993)
  • K915763 — MODIFIED DISPOSABLE FETAL VACUUM (March 18, 1992)

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