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510(k) K955657

NORTH STATE PLASTICS RESPIRATORY MOUTHPIECE by North State Plastics, Inc. — Product Code BYP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 1996
Date Received
December 12, 1995
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

Other clearances by North State Plastics, Inc.

  • K955656 — NORTH STATE PLASTICS AEROSOL TEE (March 6, 1996)

Other clearances for product code BYP

  • K944512 — TRUZONE PFM DISPOSABLE MOUTHPIECE (November 2, 1994)
  • K893791 — BREATHING MOUTHPIECE (June 23, 1989)
  • K872037 — AEROCHAMBER (July 24, 1987)
  • K865093 — SAFE-T-SHIELD MOUTHPIECE (January 15, 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)