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510(k) K770021

MASK, FACE, SURGICAL by Precept, Inc. — Product Code CAD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 1977
Date Received
January 6, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Vaporizer, Anesthesia, Non-Heated
Device Class
Class II
Regulation Number
868.5880
Review Panel
AN
Submission Type

Other clearances by Precept, Inc.

  • K771409 — DISP. SURGICAL FACE MASK (October 27, 1977)
  • K770463 — MASK, SURGICAL, FACE, DISPOSABLE (March 23, 1977)
  • K770391 — COVER, ARMBOARD, DISPOSABLE (March 7, 1977)
  • K760360 — SHIRT, MITTEN CUFF INFANT (October 20, 1976)

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  • K042276 — D-VAPOR (September 23, 2004)
  • K041076 — DELTA T (August 9, 2004)
  • K031027 — DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER (ENFLURANE) (June 26, 2003)