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510(k) K843890

CUSTOM INSTRUMENT DRAPE by Lifestream Int'L, Inc. — Product Code HMW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 1984
Date Received
October 2, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drape, Microscope, Ophthalmic
Device Class
Class II
Regulation Number
878.4370
Review Panel
HO
Submission Type

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  • K910726 — LIGHT-TOUCH AND SURGI LIGHT FIBERS (March 29, 1991)
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Other clearances for product code HMW

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  • K902763 — STERILE INSTRUMENT DRAPE (September 20, 1990)
  • K902851 — MICROSCOPE DRAPE (September 10, 1990)