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510(k) K950713

Device
AIRGUIDE STYLETTE
Applicant
POLAMEDCO, INC.
510(k) number
K950713
Product code
BSR  
Decision
Substantially Equivalent (SESE)
Decision date
1995-05-17
Date received
1995-02-15
Regulation
868.5790
Classification name
Stylet, Tracheal Tube
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
JERRY W HARRER
Address
8295 S.La Cienega Blvd. Inglewood CA US 90301 90301

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code BSR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K162729Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, and Cook Airway Exchange Catheter - Extra Firm With Soft TipCook Incorporated2017-08-11
K962361TRACHLIGHT STYLET AND TRACHEAL LIGHTWANDLaerdal Medical Corp.1996-09-05
K954771TRACHLIGHT STYLET & TRACHEAL LIGHTWAND (ORIGINAL APPLICATION NAME: STYLETT & TRACHEAL LIGHTWAND)Laerdal Medical Corp.1996-05-09
K943104MOLLOY INTUBATING STYLETTEMolloy Corp.1996-04-18
K955238RUSCH SCHROEDER ENDOTRACHEAL TUBE STYLERusch Intl.1996-02-06
K953677LIGHTED FLEXGUIDE (MODIFICATION)Scientific Sales Intl., Inc.1995-08-25
K952100RUSCH ENDOTRACHEAL TUBE STYLETRusch, Inc.1995-08-08
K952266SCHROEDER ORAL/NASAL DIRECTIONAL STYLETTEStebar Instrument Corp.1995-06-12
K950380FLEXTITIP STYLETTEPolamedco, Inc.1995-02-10
K944729STYLET SHEATH WITH LOCKING CAP AND REUSABLE BATTERY OPERATED LIGHT SOURCECoast Medical, Inc.1994-12-21
K940799FLEXGUIDEScientific Sales Intl., Inc.1994-08-18
K933598ENDOSTAR(TM) STYLETFiberoptic Medical Products, Inc.1994-01-25
K935797SCHROEDER ORAL/NASAL DIRECTIONAL STYLETTEStebar Instrument Corp.1994-01-12
K932081LIGHTED INTUBATION SYLETAaron Medical, Inc.1993-07-27
K904999WEINGARTEN TM CAPNOGRAPHIC INTUBATION STYLETTEOpticon Medical, Inc.1993-01-26

Legacy Summary#

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FDA Review#

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