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510(k) K911040

INVOTEC MICROSCOPE DRAPE by Invotec International, Inc. — Product Code HMW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 1991
Date Received
March 8, 1991
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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  • K930114 — TRACHEOSTOMY T-TUBE (March 19, 1993)
  • K911041 — INVOTEC X-RAY CASSETTE EQUIPMENT DRAPE (June 4, 1991)
  • K911039 — INVOTEC EAR DRAPE (May 13, 1991)
  • K901923 — INVOTEC POLY-MESH MANDIBULAR TRAY (October 31, 1990)

Other clearances for product code HMW

  • K902763 — STERILE INSTRUMENT DRAPE (September 20, 1990)
  • K902851 — MICROSCOPE DRAPE (September 10, 1990)
  • K843890 — CUSTOM INSTRUMENT DRAPE (October 26, 1984)