510(k) K993361
- Device
- TUBING EXTENSION SET
- Applicant
- HURRICANE MEDICAL
- 510(k) number
- K993361
- Product code
- MSR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-01-04
- Date received
- 1999-10-06
- Regulation
- 886.4150
- Classification name
- Tubing, Replacement, Phacofragmentation Unit
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAVID A CLAPP
- Address
- 2331k 63rd Ave. E. Bradenton FL US 34203 34203
FDA Registration Numbers#
- 1928237
- 2183744
Source Documents#
Other 510(k) Records For Product Code MSR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K983448 | ML UNIVERSAL TUBING | Med-Logics, Inc. | 1998-12-18 |
| K980849 | SURGIN KIT | Surgin Surgical Instrumentation, Inc. | 1998-07-09 |
| 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#
summary
FDA Review#
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