510(k) K980849
- Device
- SURGIN KIT
- Applicant
- SURGIN SURGICAL INSTRUMENTATION, INC.
- 510(k) number
- K980849
- Product code
- MSR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-07-09
- Date received
- 1998-02-05
- Regulation
- 886.4150
- Classification name
- Tubing, Replacement, Phacofragmentation Unit
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- DON HAAR
- Address
- 14762 Bentley Cir. Tustin CA US 92680 92680
FDA Registration Numbers#
- 2183744
- 1928237
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code MSR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K993361 | TUBING EXTENSION SET | Hurricane Medical | 2000-01-04 |
| K983448 | ML UNIVERSAL TUBING | Med-Logics, Inc. | 1998-12-18 |
| K980100 | STORZ DP4210 VENTURI ECONOMY ANTERIOR PACK AND DP5000 ASC DAYPACK | Storz Instrument Co. | 1998-06-01 |
| K972522 | ML-DISPOSABLE PAK | Med-Logics, Inc. | 1997-09-30 |
Legacy Summary#
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FDA Review#
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