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510(k) K810793

MOUTHPIECE, BREATHING by Dhd Medical Products Div. Diemolding Corp. — Product Code BYP

K810793 is an FDA 510(k) premarket notification submitted by Dhd Medical Products Div. Diemolding Corp. for the device "MOUTHPIECE, BREATHING". The FDA issued a decision of Substantially Equivalent on May 5, 1981. The device falls under product code BYP (Mouthpiece, Breathing), a Class I device regulated under 21 CFR 868.5620. Dhd Medical Products Div. Diemolding Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 1981
Date Received
March 23, 1981
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 Dhd Medical Products Div. Diemolding Corp.

  • K883988 — NON-REBREATHING TEE PIECE (NRTP) (October 7, 1988)
  • K881935 — MICROCIRRUS MEDICAL NEBULIZER (June 22, 1988)
  • K881178 — CUFFCHECK (April 14, 1988)
  • K873498 — INSPIRATORY FORCE MONT KIT/MANIFOLD/METER/TUBING (March 9, 1988)
  • K874047 — ASTHMAKIT (February 29, 1988)
  • K873447 — DISPOSABLE CONDENSATE BOTTLE FOR 7200 VENTILATOR (October 30, 1987)
  • K860878 — BRITISH BREATHING CIRCUIT SYSTEM (March 20, 1986)
  • K860885 — STRAIGHT CONNECTORS, 15MM, 30MM & 19MM (March 20, 1986)
  • K860882 — DISPOSABLE CATHETER (March 20, 1986)
  • K860877 — FLEXTUBE, CONNECTING TUBING (March 20, 1986)

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)
  • K865093 — SAFE-T-SHIELD MOUTHPIECE (January 15, 1987)
  • K863049 — INHALATION AID (October 15, 1986)
  • K862788 — MP-4400 MOUTHPIECE-FLANGE SEAL (August 1, 1986)
  • K853266 — PLASTIC MOUTH BARRIER HSV-I (October 29, 1985)
  • K853574 — MEDIPART DISPOS. MOUTHPIECE W/22MM O.D. MP-4411 (October 29, 1985)
  • K853575 — MEDIPART MOUTHPIECE MP-1010 (October 29, 1985)

FDA data resources