FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STORZ DP4210 VENTURI ECONOMY ANTERIOR PACK AND DP5000 ASC DAYPACK
K Number: K980100
·
Decision Jun 1, 1998
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
4
Applicant Total
101
Review Days
140
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Basic Information
- Device Name
- STORZ DP4210 VENTURI ECONOMY ANTERIOR PACK AND DP5000 ASC DAYPACK
- K Number
- K980100
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4150
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Storz Instrument Co.
- Date Received
- January 12, 1998
- Decision Date
- June 1, 1998
- Product Code
- MSR
- Advisory Committee
- Ophthalmic
- 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 |
|---|---|---|---|
| MSR | Tubing, Replacement, Phacofragmentation Unit | FDA class 2 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MSR), ordered by most recent decision date.
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ML-DISPOSABLE PAK
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|---|---|---|---|
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| K961874 | STORZ DP5100 ANTERIOR COLLECTION CASSETTE PACK | Aug 6, 1996 | Substantially Equivalent |