510(k) K890728
- Device
- STERILE IRRIGATION TRAYS
- Applicant
- CYPRESS MEDICAL PRODUCTS, LTD.
- 510(k) number
- K890728
- Product code
- KYZ
- Decision
- Substantially Equivalent - With Drug (SESD)
- Decision date
- 1989-06-16
- Date received
- 1989-02-13
- Regulation
- 880.6960
- Classification name
- Syringe, Irrigating (non Dental)
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- VARUN SONI
- Address
- 1202 S. Rte. 31 Mc Henry IL US 60050 60050
FDA Registration Numbers#
- 3007644779
- 3006157842
- 1250045
- 3004111573
- 2029275
- 3017907716
- 1064619
- 3009308092
- 1017768
- 1037752
- 3006973666
- 9616250
- 3009499159
- 3026848699
- 3012185136
- 1210513
- 3009420598
- 3012684779
- 3016660845
- 3003887292
- 3006538822
- 3006552462
- 3004519921
- 1000393132
- 3016734024
- 9614279
- 3007007790
- 3011182134
- 3024999438
- 8040233
- 3016099078
- 3016872092
- 1061124
- 3012507533
- 3005809810
- 2220100
- 1915484
- 3015238043
- 1420054
- 3007583964
- 3010515547
- 2648727
- 1055236
- 3015337348
- 3009307523
- 3010380518
- 1422443
- 3012314549
- 8022210
- 3008280537
- 3000215556
- 3038611387
- 3013557562
- 3007456622
- 3036893546
- 9611102
- 3008502431
- 3010131137
- 1423537
- 2183744
- 3009104075
- 3004099493
- 3010332886
- 1423662
- 9611665
- 1216677
- 3006181312
- 2023739
- 3014615697
- 3003207991
- 3005934752
- 3009888344
- 9710641
- 3017961114
- 1828132
- 3014421917
- 3010337881
- 3012416077
- 3031231776
- 9614062
Source Documents#
510(k) summary PDF not indicated by FDA
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 |
| K964833 | RMI DUAL FLUID IRRIGATING SYRINGE | Research Medical, Inc. | 1997-02-19 |
| 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 |
Legacy Summary#
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FDA Review#
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