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510(k) K896821

Device
OLYMPUS URETERO. & CIRCON ACMI URETERO. GUIDE
Applicant
NORTH AMERICAN STERILIZATION & PACKAGING CO.
510(k) number
K896821
Product code
KOQ  
Decision
Substantially Equivalent (SESE)
Decision date
1990-02-09
Date received
1989-12-04
Regulation
872.3410
Classification name
Adhesive, Denture, Carboxymethylcellulose Sodium (40-100&)
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
A SCHLAKMAN
Address
15 White Lake Rd. P.O. Box 923 Sparta NJ US 07871 07871

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KOQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K901882URESIL ENDOSCOPIC LASER OVERTUBEUresil Corp.1990-07-27
K900401NAS&P GRASPING FORCEPS & ASSOC. DEVICESNorth American Sterilization & Packaging Co.1990-02-09
K831265DENTOLOCK DENTURE ADHESIVE CREAMSolar Dental Co., Inc.1983-05-09

Legacy Summary#

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FDA Review#

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