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510(k) K822711

Device
ANTI-MIST, ANTI-FOG EYEGLASS & DENTAL
Applicant
PARKER LABORATORIES, INC.
510(k) number
K822711
Product code
FAX  
Decision
Substantially Equivalent (SESE)
Decision date
1982-11-03
Date received
1982-09-07
Regulation
876.5520
Classification name
Bougie, Urological
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
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 FAX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K950125KARL STORZ BOUGIES AND DILATORSKARL STORZ Endoscopy-America, Inc.1995-02-07

Legacy Summary#

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FDA Review#

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