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#
- 3042200051
- 3004468406
- 1423537
- 2032476
- 3006538822
- 3034669683
- 3027473313
- 3005809810
- 3010400367
- 1047843
- 3016884033
- 2433012
- 3007644779
- 3009937681
- 3013630887
- 3005418739
- 1054241
- 1928237
- 3002808270
- 3038285060
- 3031700059
- 9611665
- 9610825
- 3016267994
- 1220477
- 8040179
- 1287329
- 3032109
- 3014570560
- 3010177471
- 2243072
- 2084346
- 2530138
- 1820334
- 3015277818
- 3008489813
- 3004911384
- 9612030
- 1061124
- 3036722184
- 3015967359
- 1422443
- 3030733800
- 2320762
- 3014252464
- 3009104075
- 8031007
- 3038294399
- 3015745029
- 2028807
- 3003207991
- 3005245797
- 3038611387
- 3017961114
- 9616410
- 9681260
- 3005934752
- 8040233
- 3031184338
- 3019555526
- 3003244954
- 2032809
- 3008384335
- 3009308092
- 9614062
- 3006536657
- 3005669815
- 3011270181
- 3004550973
- 3006891667
- 1030451
- 3010332886
- 3007137643
- 3012416077
- 3005987240
- 3026844237
- 1650927
- 1317900
- 3005841027
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 |
| K952407 | REDI NURSE SYSTEM (RNS) PRE-FILLED 10CC, 30CC, 60CC SYRINGE W/STERILE WATER | Contour Fabricators of Florida, Inc. | 1995-08-07 |
| K952406 | REDI NURSE SYSTEM (RNS) PRE-FILLED 60CC IRRIGATION SYRINGE W/STERILE SODIUM CHLORIDE SOLUTION | 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#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases