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510(k) K831008

HEAD STRAP by Medovations, Inc. — Product Code BTK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1983
Date Received
March 30, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Strap, Head, Gas Mask
Device Class
Class I
Regulation Number
868.5560
Review Panel
AN
Submission Type

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Other clearances for product code BTK

  • K944949 — GENERAL ANESTHESIA SYSTEM (November 14, 1994)
  • K914335 — STRAP, HEAD, GAS MASK (April 2, 1992)
  • K854537 — HEADSTRAP (December 3, 1985)
  • K853573 — MEDIPART FACE MASK HEADSTRAP MP-9100 (October 29, 1985)
  • K810991 — HEADSTRAP (April 29, 1981)