FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STORZ MILLENNIUM VISCOUS FLUID SYSTEM
K Number: K972664
·
Decision Oct 10, 1997
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
18
Applicant Total
101
Review Days
86
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Basic Information
- Device Name
- STORZ MILLENNIUM VISCOUS FLUID SYSTEM
- K Number
- K972664
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Storz Instrument Co.
- Date Received
- July 16, 1997
- Decision Date
- October 10, 1997
- Product Code
- MRH
- Advisory Committee
- General Hospital
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| MRH | Pump, Infusion, Ophthalmic | FDA class 2 | General Hospital |
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Other Clearances by Storz Instrument Co.
| K Number | Device Name | ||
|---|---|---|---|
| K980100 | STORZ DP4210 VENTURI ECONOMY ANTERIOR PACK AND DP5000 ASC DAYPACK | Jun 1, 1998 | Substantially Equivalent |
| K980488 | STORZ MILLENNIUM MICROSURGICL SYSTEM HIGH SPEED VITRECTOMY SYSTEM | Mar 23, 1998 | Substantially Equivalent |
| K971439 | STORZ MICROFLOW AND STORZ STANDARD PHACOEMULSIFICATION NEEDLES | Jun 17, 1997 | Substantially Equivalent |
| K964743 | STORZ E8010 ERGOTEC/PREMIERE ADAPTOR | Feb 3, 1997 | Substantially Equivalent |
| K960024 | STORZ D7120 PHACO HANDPIECE MAINTENANCE KIT & STORZ D7125 PHACO HANDPIECE NEEDLE WRENCH | Sep 20, 1996 | Substantially Equivalent |
| K960061 | STORZ D7108 MICROSCISSORS HANDPIECE/STORZ D7106 MICROSCISSORS DRIVE TUBE | Sep 18, 1996 | Substantially Equivalent |
| K960003 | STORZ D7116 MICROVIT VITRECTOMY CUTTER EXTENSION | Aug 29, 1996 | Substantially Equivalent |
| K962131 | STORZ D4600 AIR EXCHANGE LINE PACK | Aug 23, 1996 | Substantially Equivalent |
| K961831 | STORZ DP5200 IRRIGATION ADDMINISTRATION SET PACK | Aug 6, 1996 | Substantially Equivalent |
| K961874 | STORZ DP5100 ANTERIOR COLLECTION CASSETTE PACK | Aug 6, 1996 | Substantially Equivalent |