FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ICAN NEEDLE COUNTERS
K Number: K913446
·
Decision Sep 13, 1991
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
112
Applicant Total
30
Review Days
42
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Basic Information
- Device Name
- ICAN NEEDLE COUNTERS
- K Number
- K913446
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Icn Pharmaceuticals, Inc.
- Date Received
- August 2, 1991
- Decision Date
- September 13, 1991
- Product Code
- MMK
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| MMK | Container, Sharps | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MMK), ordered by most recent decision date.
Guanhong Sharps Container (GHW-1F1); Guanhong Sharps Container (GHW-1F4); Guanhong Sharps Container (GH-6FA); Guanhong Sharps Container (GHW-2FR); Guanhong Sharps Container (GHW-8FR); Guanhong Sharps Container (GH-3FS); Guanhong Sharps Container (GHW-15FS); Guanhong Sharps Container (GHW-27FS); Guanhong Sharps Container (GH-5FSW); Guanhong Sharps Container (GHW-3FT); Guanhong Sharps Container (GHW-4FT); Guanhong Sharps Container (GHW-5FT); Guanhong Sharps Container (GHW-8FT); Guanhong
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Other Clearances by Icn Pharmaceuticals, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K022817 | COOLTOUCH ND:YAG LASER SYSTEM, MODEL COOLTOUCH, COOLTOUCH-II ND:YAG LASER SYSTEM, MODEL COOLTOUCH-II | Nov 22, 2002 | Substantially Equivalent |
| K951329 | IMMUCHEM GAL-MW EA | Nov 9, 1995 | Substantially Equivalent |
| K914530 | ICAN GT DRAINAGE BAG | Dec 18, 1991 | Substantially Equivalent |
| K914082 | SUAN FLAT DISSECTOR SPONGES | Nov 27, 1991 | Substantially Equivalent |
| K914083 | ICAN K DISSECTOR SPONGES | Oct 9, 1991 | Substantially Equivalent |
| K914086 | ICAN CYLINDRICAL SPONGES | Oct 9, 1991 | Substantially Equivalent |
| K914081 | ICAN COTTON RAYON BALLS | Oct 9, 1991 | Substantially Equivalent |
| K904398 | WATER COLUMN RELIEF VALVE | Jul 9, 1991 | Substantially Equivalent |
| K770458 | BILIRUBIN PROCEDURE, TEKPOINT TOT & DIR. | May 10, 1977 | Substantially Equivalent |
| K770453 | PHOSPHATASE PROCEDURE, TEKPOINT ALKALINE | May 3, 1977 | Substantially Equivalent |