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510(k) K840342

PDI PREPMASTER WET PACK PATIENT PREP KIT by Nice-Pak Products, Inc. — Product Code FRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 1984
Date Received
January 6, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wrap, Sterilization
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type

Other clearances by Nice-Pak Products, Inc.

  • K974768 — PDI STERILE LUBRICATING JELLY (January 16, 1998)
  • K840343 — PDI PREPMASTER WET PACK VAGINAL-X21477 (March 27, 1984)
  • K840344 — PDI PREPMASTER WET PACK MINOR PROCEDURE (March 26, 1984)
  • K833549 — PDI SURGICAL SCRUB/BRUSH T150-70 (November 28, 1983)
  • K810337 — PDI SURGICAL SCRUB SPONGE-BRUSH-T15070 (February 26, 1981)
  • 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 FRG

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  • K251177 — Self-Seal Sterilization Pouch and Roll (December 12, 2025)
  • K250306 — Chex-All Sterilization Pouches and Tubes (October 31, 2025)
  • K243179 — Sterilization Pouch and Roll (June 26, 2025)
  • K250321 — GCI Sterilization Wrappers (June 6, 2025)
  • K243721 — Self Sealing Sterilization Pouches (April 25, 2025)
  • K250011 — Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS120 (April 4, 2025)
  • K241565 — Sterilization Package/Reel (February 24, 2025)
  • K243431 — Medicom Sterilization Pouch and Reel (February 21, 2025)
  • K242898 — Sterilization Pouches and Reels (February 21, 2025)