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 | Device Class | Medical Specialty |
|---|---|---|---|
| KOQ | Adhesive, Denture, Carboxymethylcellulose Sodium (40-100&) | FDA class 1 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KOQ), ordered by most recent decision date.
URESIL ENDOSCOPIC LASER OVERTUBE
FDA 510(k)
FDA Class 1
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NAS&P GRASPING FORCEPS & ASSOC. DEVICES
FDA 510(k)
FDA Class 1
·Dental
DENTOLOCK DENTURE ADHESIVE CREAM
FDA 510(k)
FDA Class 1
·Dental
Other Clearances by North American Sterilization & Packaging Co.
| K Number | Device Name | ||
|---|---|---|---|
| K964231 | NASP HYDROCOLLOID DRESSING (REGULAR OR THIN) | Mar 10, 1997 | Substantially Equivalent |
| K963753 | NASP TRANSPARENT DRESSING | Nov 29, 1996 | Substantially Equivalent |
| K962352 | HYDROGEL SKIN DRESSING | Aug 2, 1996 | Substantially Equivalent |
| K925588 | NORTEC STER SALINE-O.9% SODIUM CHLOR FOR DEV IRRI | Dec 3, 1993 | Substantially Equivalent |
| K925593 | NORTEC STERILE WATER FOR DEVICE IRRIGATION | Dec 3, 1993 | Substantially Equivalent |
| K925161 | NORTEC STERILE WATER FOR CATHETER BALLOON INFLATIO | Jul 21, 1993 | Substantially Equivalent |
| K911865 | NORTEC CONNECTING TUBE SET | Nov 1, 1991 | Substantially Equivalent |
| K911784 | NORTEC ROBERTAZZI NASOPHARYNGEAL AIRWAY | Sep 23, 1991 | Substantially Equivalent |
| K910691 | NORTEC URETERAL STENT | Aug 15, 1991 | Substantially Equivalent |
| K903162 | FLEXIBLE ENDOSCOPIC ELECTRODES | Dec 18, 1990 | Substantially Equivalent |