STORZ DP4210 VENTURI ECONOMY ANTERIOR PACK AND DP5000 ASC DAYPACK
FDA 510(k) clearance K980100 · decided 1998-06-01
Clearance details
- K-number
- K980100
- Device name
- STORZ DP4210 VENTURI ECONOMY ANTERIOR PACK AND DP5000 ASC DAYPACK
- Applicant
- Storz Instrument Co.
- Decision
- Substantially Equivalent
- Date received
- 1998-01-12
- Decision date
- 1998-06-01
- Days to decision
- 140 days
- Clearance type
- Traditional
- Product code
- MSR
- Device class
- 2
- Regulation number
- 886.4150
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- St. Louis, MO, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| TUBING EXTENSION SET (K993361) | Hurricane Medical | 2000-01-04 |
| ML UNIVERSAL TUBING (K983448) | Med-Logics, Inc. | 1998-12-18 |
| SURGIN KIT (K980849) | Surgin Surgical Instrumentation, Inc. | 1998-07-09 |
| ML-DISPOSABLE PAK (K972522) | Med-Logics, Inc. | 1997-09-30 |
Recalls involving this device
No recalls on record reference this clearance.