FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

OLYMPUS URETERO. & CIRCON ACMI URETERO. GUIDE

K Number: K896821 · Decision Feb 9, 1990
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
3
Applicant Total
16
Review Days
67

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Basic Information

Device Name
OLYMPUS URETERO. & CIRCON ACMI URETERO. GUIDE
K Number
K896821
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
872.3410
Medical Specialty
Dental
Decision
Substantially Equivalent
Applicant
North American Sterilization & Packaging Co.
Date Received
December 4, 1989
Decision Date
February 9, 1990
Product Code
KOQ
Advisory Committee
Dental
Review Advisory Committee
DE
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
KOQ Adhesive, Denture, Carboxymethylcellulose Sodium (40-100&)

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (KOQ), ordered by most recent decision date.

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Other Clearances by North American Sterilization & Packaging Co.

K Number Device Name
K964231 NASP HYDROCOLLOID DRESSING (REGULAR OR THIN)
K963753 NASP TRANSPARENT DRESSING
K962352 HYDROGEL SKIN DRESSING
K925588 NORTEC STER SALINE-O.9% SODIUM CHLOR FOR DEV IRRI
K925593 NORTEC STERILE WATER FOR DEVICE IRRIGATION
K925161 NORTEC STERILE WATER FOR CATHETER BALLOON INFLATIO
K911865 NORTEC CONNECTING TUBE SET
K911784 NORTEC ROBERTAZZI NASOPHARYNGEAL AIRWAY
K910691 NORTEC URETERAL STENT
K903162 FLEXIBLE ENDOSCOPIC ELECTRODES
Search all 16 clearances from North American Sterilization & Packaging Co. →