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510(k) K032192

PRE-VACUUM AUTOCLAVE WITH STEAM GENERATOR AND VERTICAL SLIDING DOOR, MODELS 4472 EP-1V AND 5596 EP-1V by Tuttnauer U.S.A Co, Ltd. — Product Code FLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 2004
Date Received
July 17, 2003
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilizer, Steam
Device Class
Class II
Regulation Number
880.6880
Review Panel
HO
Submission Type

Other clearances by Tuttnauer U.S.A Co, Ltd.

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  • K090783 — TUTTNAUER ELARA-11 PRE-VACUUM TABLETOP AUTOCLAVE (August 20, 2009)
  • K021504 — TUTTNAUER EHS SERIES TABLE-TOP AUTOCLAVE, MODEL 2540 (July 25, 2002)
  • K993856 — TUTTNAUER ELECTRONIC AUTOCLAVE, MODELS E, EA, EK, EKA, EP (February 9, 2001)
  • K990761 — TUTTNAUER MINI CONTAINER CASSETTE, TUTTNAUER STANDARD CASE CASSETTE (July 9, 1999)
  • K962282 — TUTTNAUER PREVACUUM TABLE AUTOCLAVE (November 12, 1997)
  • K973550 — TUTTNAUER TABLE-TOP AUTOCLAVE (October 29, 1997)

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  • K250164 — Cassette Autoclave (ACA5) (August 14, 2025)
  • K243994 — Steam Sterilizer (2545D) (June 6, 2025)
  • K243801 — FRONT-LINE Field Sterilizer (FL135) (March 7, 2025)
  • K233026 — Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer (April 4, 2024)
  • K233504 — Lexa MINI (RIS-303, RIS-305) (February 8, 2024)
  • K233132 — PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB) (December 19, 2023)
  • K232658 — T-Top 10 & T-Top T-Top 11 (November 27, 2023)