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510(k) K803069

Device
SHELL KRATON THERMO-PLASTIC RUBBER COMP.
Applicant
WARREN E. COLLINS, INC.
510(k) number
K803069
Product code
BYP  
Decision
Substantially Equivalent (SESE)
Decision date
1980-12-22
Date received
1980-12-05
Regulation
868.5620
Classification name
Mouthpiece, Breathing
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code BYP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K955657NORTH STATE PLASTICS RESPIRATORY MOUTHPIECENorth State Plastics, Inc.1996-03-12
K944512TRUZONE PFM DISPOSABLE MOUTHPIECEMonaghan Medical Corp.1994-11-02
K893791BREATHING MOUTHPIECEDiemolding Corp.1989-06-23
K872037AEROCHAMBERMonaghan Medical Corp.1987-07-24
K865093SAFE-T-SHIELD MOUTHPIECEMedi Nuclear Corp., Inc.1987-01-15
K863049INHALATION AIDBoehringer Ingelheim Pharmaceuticals, Inc.1986-10-15
K862788MP-4400 MOUTHPIECE-FLANGE SEALMedipart Jerry Alexander1986-08-01
K853575MEDIPART MOUTHPIECE MP-1010Medipart Jerry Alexander1985-10-29
K853574MEDIPART DISPOS. MOUTHPIECE W/22MM O.D. MP-4411Medipart Jerry Alexander1985-10-29
K853572MEDIPART DISPOS. MOUTHPIECE W/2MM I.D. MP-4410Medipart Jerry Alexander1985-10-29
K853266PLASTIC MOUTH BARRIER HSV-IWestmark Enterprises, Inc.1985-10-29
K853402E-Z-GUARD MOUTHPIECEE-Z-Em, Inc.1985-10-23
K840459IMPROVED MOUTHPIECEKinetix1984-02-17
K833420KINETIX MOUTHPIECEKinetix1984-01-10
K822437MONAGHAN AEROCHAMBERMonaghan Medical Corp.1982-11-03

Legacy Summary#

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FDA Review#

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