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510(k) K770586

UNIVERSAL MOUTHPIECE, #750 by Surgicot, Inc. — Product Code BYP

K770586 is an FDA 510(k) premarket notification submitted by Surgicot, Inc. for the device "UNIVERSAL MOUTHPIECE, #750". The FDA issued a decision of Substantially Equivalent on April 5, 1977. The device falls under product code BYP (Mouthpiece, Breathing), a Class I device regulated under 21 CFR 868.5620. Surgicot, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 1977
Date Received
March 28, 1977
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 Surgicot, Inc.

  • K962605 — PRO-GUARD DOUBLE-DUTY STERILIZATION WRAP (SINGLE USE) (March 11, 1997)
  • K931270 — SURGICLEAN ENZYMATIC INSTRUMENT CLEANER (April 13, 1994)
  • K863122 — ASSERT BIOLOGICAL/CHEMICAL INDICATOR 12 MONTH EXP. (December 17, 1986)
  • K855101 — ASSERT TM BIOLOGICAL/CHEMICAL INDICATOR (July 17, 1986)
  • K854631 — ASSERT EO BIOLOGICAL TEST PACK (May 27, 1986)
  • K854902 — SURGICOT STEAM TEST PACK (May 20, 1986)
  • K840541 — NEURO SPONGE (April 23, 1984)
  • K840471 — EYE SPEAR (March 16, 1984)
  • K840470 — SURGISCRIBE MARKING PEN (March 12, 1984)
  • K830739 — PRO-GUARD (March 29, 1983)

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