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510(k) K770396

DRAPES, MODESTY by Mark One Healthcare Products — Product Code KKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 1977
Date Received
March 1, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Mark One Healthcare Products

  • K891986 — MULTIPLE-VARIOUS TYPES OF ABSORBENT INCONTINENCE (December 29, 1989)
  • K833867 — PAREMA K BAND NON-STERILE (January 27, 1984)
  • K833084 — MASTERHINGE (October 14, 1983)
  • K761268 — SKIN PRESSURE PROTECTORS (February 16, 1977)

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