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510(k) K940864

DENTIST WITH ASSISTANT PACK by Sterile Concepts, Inc. — Product Code EIA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 1994
Date Received
February 23, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Operative Dental
Device Class
Class I
Regulation Number
872.6640
Review Panel
DE
Submission Type

Other clearances by Sterile Concepts, Inc.

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  • K952539 — RADIOLOGY PACKS (July 14, 1995)
  • K951478 — GENERAL AND PLASTIC SURGERY PACKS (June 13, 1995)
  • K944139 — DENTAL HYGIENE TRAY (December 15, 1994)
  • K943047 — IV START KITS (September 14, 1994)
  • K943090 — SUTURE REMOVAL TRAYS (August 22, 1994)
  • K943046 — SKIN STAPLE REMOVAL TRAYS (July 29, 1994)
  • K920763 — LACERATTION TRAY (September 28, 1992)

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