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510(k) K932305

Device
VILA-COOKE(TM) ANESTHESIA PILLOW
Applicant
SHARN, INC.
510(k) number
K932305
Product code
CCX  
Decision
Substantially Equivalent (SESE)
Decision date
1993-10-05
Date received
1993-05-12
Regulation
868.6820
Classification name
Support, Patient Position
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JOHN F SPANGLER
Address
4801 George Rd., #180 Tampa FL US 33634 33634

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code CCX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K943837CHIN UPEdward Carden1994-10-14
K934235SNIFF POSITION PILLOWAmerican Medical Development, Inc.1993-10-01
K861915SURGICAL HEAD SUPPORTTreace Medical, Inc.1986-05-30
K833022AIR UTERINE DISPLACER-AUD 120Scientific Sales Intl., Inc.1983-10-14
K821838VARI-SUPPORT LOW BACK POSTURE PILLOWBody Therapeutics, Inc.1982-07-20
K810035PRENATAL SUPPORT PILLOWSupportech, Inc.1981-01-23
K801330ANSPACH LEG SUPPORTThe Anspach Effort, Inc.1980-06-26

Legacy Summary#

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FDA Review#

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