510(k) K960212
- Device
- CPR IRRIGATION TRAY
- Applicant
- CUSTOM PACK RELIABILITY
- 510(k) number
- K960212
- Product code
- KYZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-04-01
- Date received
- 1996-01-16
- 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
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- RICHARD L ELLWOOD
- Address
- 4207 Vineland Rd., M-1 Orlando FL US 32811 32811
FDA Registration Numbers#
- 1123137
- 3042200051
- 1422443
- 1060680
- 3010041511
- 1832653
- 3010131137
- 3009420598
- 3015173212
- 3010594263
- 3004993040
- 3004519921
- 3033589330
- 3006542501
- 1313525
- 3025428426
- 3001620590
- 3006673317
- 3012316249
- 3003965134
- 9614279
- 3012568936
- 3005669815
- 2183416
- 1649395
- 1820334
- 1066491
- 3015058854
- 3007060769
- 3016734024
- 1720929
- 8031007
- 3010337881
- 3013557562
- 3011689956
- 3020468145
- 9616250
- 3016707060
- 3011983031
- 1416980
- 3007125392
- 3002579136
- 3026848699
- 3007137643
- 3009746061
- 1417592
- 9617744
- 3031233007
- 3006542380
- 2246990
- 9680934
- 1216677
- 3006897996
- 1721504
- 3014637079
- 9610621
- 3016872092
- 3017429279
- 3006950086
- 1937141
- 1932180
- 3005809810
- 3012972093
- 3004215929
- 9710641
- 9611102
- 1043646
- 3005271071
- 3038356900
- 3005099803
- 3005448067
- 3031700059
- 3012314549
- 3008719017
- 1643817
- 3031915926
- 1526534
- 3010177471
- 3005245797
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 |
| 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#
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FDA Review#
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