510(k) K964833
- Device
- RMI DUAL FLUID IRRIGATING SYRINGE
- Applicant
- RESEARCH MEDICAL, INC.
- 510(k) number
- K964833
- Product code
- KYZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-02-19
- Date received
- 1996-12-02
- Regulation
- 880.6960
- Classification name
- Syringe, Irrigating (non Dental)
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- RD HIBBERT
- Address
- 6864 S. 300 W. Midvale UT US 84047 84047
FDA Registration Numbers#
- 2084346
- 3004416208
- 2523676
- 9680890
- 1422634
- 2220100
- 3005099803
- 3010621964
- 2020550
- 9680718
- 9611102
- 9616250
- 3034669683
- 3038356900
- 9611503
- 3004941127
- 1423662
- 8041151
- 3031915926
- 1035907
- 3011182134
- 3016660845
- 3009104075
- 1820334
- 3007060769
- 9710020
- 3017961114
- 3010419931
- 3007682555
- 3014159736
- 3020468145
- 3004468406
- 9610621
- 3023174629
- 1000121056
- 1000393132
- 2032809
- 3032109
- 3042367543
- 3031233007
- 1054241
- 3009888344
- 3016872092
- 3007644779
- 3011707784
- 3012445205
- 3016851379
- 3003887292
- 2023739
- 3031184338
- 3008693658
- 3006610790
- 3010041511
- 3013443304
- 2183744
- 8043816
- 3005271071
- 3009140376
- 3012421607
- 1250045
- 3005905524
- 3010594263
- 3010332886
- 3012070313
- 2530138
- 3009308092
- 3004111573
- 1423507
- 3005987240
- 9612030
- 3018074706
- 3005448067
- 3003418325
- 3017770710
- 3008489813
- 8043685
- 3006730167
- 8022210
- 3031700059
- 3005670221
Source Documents#
Other 510(k) Records For Product Code KYZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K201877 | OtoSet- Ear Cleaning System | Safkan, Inc. | 2020-11-05 |
| K102563 | SINGLE CANNULA EXTENDED APPLICATOR | Micromedics, Inc. | 2011-03-15 |
| K092022 | TISSU TRANS HARVEST TUBING | Shippert Medical Technologies Corp. | 2009-08-17 |
| K050797 | TISSU-TRANS | Shippert Medical Technologies Corp. | 2005-07-13 |
| K991254 | QS DELIVERY SYSTEM | Sub-Q, Inc. | 1999-08-23 |
| K982435 | IRRIGATION SYRINGE KIT | Sub-Q, Inc. | 1998-11-06 |
| K974288 | ZEROWET SPLASHIELD | Zerowet, Inc. | 1998-01-29 |
| K960725 | MARPP PRESSURE MONITORING SYSTEM | Paradigm Medical, Inc. | 1996-07-15 |
| K960212 | CPR IRRIGATION TRAY | Custom Pack Reliability | 1996-04-01 |
| K952406 | REDI NURSE SYSTEM (RNS) PRE-FILLED 60CC IRRIGATION SYRINGE W/STERILE SODIUM CHLORIDE SOLUTION | Contour Fabricators of Florida, Inc. | 1995-08-07 |
| K952407 | REDI NURSE SYSTEM (RNS) PRE-FILLED 10CC, 30CC, 60CC SYRINGE W/STERILE WATER | Contour Fabricators of Florida, Inc. | 1995-08-07 |
| K933171 | INMAN IRRIGATION TAPERED PROBE | Inman Medical Corp. | 1994-04-29 |
| K940371 | SURGICAL SEALANT APPLICATOR TIP ENDOSCOPIC TIP | Micromedics, Inc. | 1994-04-06 |
| K930610 | TALC DISPENSER SYRINGE | Nusurg, Inc. | 1993-11-04 |
| K924517 | AVITENE DISPENSER SYRINGE | Nusurg, Inc. | 1993-10-27 |
Legacy Summary#
summary
FDA Review#
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