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510(k) K810337

PDI SURGICAL SCRUB SPONGE-BRUSH-T15070 by Nice-Pak Products, Inc. — Product Code GEC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 1981
Date Received
February 9, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Brush, Scrub, Operating-Room
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Nice-Pak Products, Inc.

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  • K840343 — PDI PREPMASTER WET PACK VAGINAL-X21477 (March 27, 1984)
  • K840342 — PDI PREPMASTER WET PACK PATIENT PREP KIT (March 27, 1984)
  • K840344 — PDI PREPMASTER WET PACK MINOR PROCEDURE (March 26, 1984)
  • K833549 — PDI SURGICAL SCRUB/BRUSH T150-70 (November 28, 1983)
  • K781539 — ISO-CARE KIT (November 3, 1978)
  • K780279 — ICE-PAK, PDI (April 10, 1978)
  • K780400 — DEN-Z-ORB (March 27, 1978)

Other clearances for product code GEC

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  • K960621 — EXPANDACELL INSTRUMENT WIPE (April 1, 1996)
  • K900691 — BIODYNE INSTRUMENT WIPES (March 8, 1990)
  • K896085 — SURGI-BRUSH (November 8, 1989)
  • K875033 — STERILE SCRUBBY SCRUB BRUSH (February 19, 1988)
  • K875129 — STERI-CLENS (February 18, 1988)
  • K872823 — DELTA SCRUB (January 7, 1988)
  • K874653 — STERILE SURGICAL SCRUB BRUSH (December 30, 1987)
  • K874741 — STERI-CLENS(TM) SURGICAL SCRUB SPONGE (December 10, 1987)
  • K870258 — BIOSCRUB SURGICAL SCRUB BRUSH (February 24, 1987)