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510(k) K874554

ENVICLUSIVE (TM) by Marion Laboratories, Inc. — Product Code NAD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1988
Date Received
November 4, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Occlusive
Device Class
Class I
Regulation Number
878.4020
Review Panel
SU
Submission Type

Other clearances by Marion Laboratories, Inc.

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  • K874552 — ENVISAN PAD (January 22, 1988)
  • K874551 — ENVINET(TM) (January 22, 1988)
  • K874553 — ENVISAN PASTE (December 18, 1987)
  • K870864 — CULTURETTE BRAND CDT CLOSTRIDIUM DIFFICILE TEST (April 14, 1987)
  • K863485 — MODIFICATION OF CDT(TM) CLOSTRIDIUM TEST (September 17, 1986)
  • K862123 — BIOSPHERE ANAEROBIC ENVIRONMENTAL DEVICE (June 16, 1986)
  • K853073 — CULTURETTE BRAND 10-MINUTE GROUP A STREP I.D. (August 1, 1985)

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