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510(k) K833084

MASTERHINGE by Mark One Healthcare Products — Product Code LGF

K833084 is an FDA 510(k) premarket notification submitted by Mark One Healthcare Products for the device "MASTERHINGE". The FDA issued a decision of Substantially Equivalent on October 14, 1983. The device falls under product code LGF (Component, Cast), a Class I device regulated under 21 CFR 888.5940. Mark One Healthcare Products has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 1983
Date Received
September 13, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Component, Cast
Device Class
Class I
Regulation Number
888.5940
Review Panel
OR
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)
  • K770396 — DRAPES, MODESTY (March 23, 1977)
  • K761268 — SKIN PRESSURE PROTECTORS (February 16, 1977)

Other clearances for product code LGF

  • K043526 — SILVERSEAL TUBULAR WOUND DRESSING WITH X-STATIC (March 10, 2005)
  • K973420 — CLINITEX CAST PADDING (December 9, 1997)
  • K973417 — CLINITEX STOCKINETTE (December 9, 1997)
  • K955320 — PROTEC COTTON PADDING BANDAGE (January 26, 1996)
  • K932507 — QUICK-CAST IMMOBILIZER (February 23, 1994)
  • K931672 — CARAPACE STERILE CAST PADDING (December 15, 1993)
  • K910274 — ARTIFLEX(TM) (March 5, 1991)
  • K903946 — COOL CAST(R) (December 31, 1990)
  • K896634 — CARAGLAS XTRA SYNTHETIC CASTING TAPE (June 14, 1990)
  • K883294 — SYNTHETIC CAST TAPE (August 30, 1988)

FDA data resources