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510(k) K865093

SAFE-T-SHIELD MOUTHPIECE by Medi Nuclear Corp., Inc. — Product Code BYP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 1987
Date Received
December 30, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mouthpiece, Breathing
Device Class
Class I
Regulation Number
868.5620
Review Panel
AN
Submission Type

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  • K915075 — NEBULIZER (DIRECT PATIENT INTERFACE) (July 16, 1992)
  • K865107 — AERO-VENT AEROSOL UNIT (October 20, 1987)
  • K863996 — MODEL XE-103 XENON/MASTER II (November 4, 1986)
  • K813379 — RADIONUCLIDE DOSE CALIBRATOR (January 22, 1982)
  • K810819 — MEDI/NUCLEAR #XE-102 XENON/MASTER (April 14, 1981)

Other clearances for product code BYP

  • K955657 — NORTH STATE PLASTICS RESPIRATORY MOUTHPIECE (March 12, 1996)
  • K944512 — TRUZONE PFM DISPOSABLE MOUTHPIECE (November 2, 1994)
  • K893791 — BREATHING MOUTHPIECE (June 23, 1989)
  • K872037 — AEROCHAMBER (July 24, 1987)
  • K863049 — INHALATION AID (October 15, 1986)
  • K862788 — MP-4400 MOUTHPIECE-FLANGE SEAL (August 1, 1986)
  • K853575 — MEDIPART MOUTHPIECE MP-1010 (October 29, 1985)
  • K853574 — MEDIPART DISPOS. MOUTHPIECE W/22MM O.D. MP-4411 (October 29, 1985)
  • K853572 — MEDIPART DISPOS. MOUTHPIECE W/2MM I.D. MP-4410 (October 29, 1985)
  • K853266 — PLASTIC MOUTH BARRIER HSV-I (October 29, 1985)