510(k) K896800
- Device
- IRRIGATION TRAY
- Applicant
- WESTMARK, STERILE PACKING SYSTEMS, INC. (SPS)
- 510(k) number
- K896800
- Product code
- KYZ
- Decision
- Substantially Equivalent - Kit (SESK)
- Decision date
- 1990-05-24
- Date received
- 1989-12-01
- 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
- SURY SHONEY
- Address
- 1253 Ramona St. SE Grand Rapids MI US 49507 49507
FDA Registration Numbers#
- 1043646
- 3016851379
- 3004941127
- 3017618922
- 1820334
- 3015142721
- 1828132
- 1000121056
- 3007125392
- 3016660845
- 3007007790
- 3003887292
- 3013557562
- 3005273623
- 3016734024
- 3008412545
- 3005327291
- 3009104075
- 2246990
- 3005593675
- 3007663056
- 3011270181
- 1423507
- 8031007
- 1423662
- 3008427684
- 3010288346
- 3012507533
- 1928237
- 3012002722
- 2183650
- 3008384335
- 3005099803
- 3013057712
- 3006973666
- 3005515211
- 3005202235
- 3013298431
- 3004215929
- 1825146
- 1030451
- 3009140376
- 3006610790
- 1416980
- 3017429279
- 3016659819
- 9681260
- 3004416208
- 3023174629
- 3035642068
- 3018503755
- 1210513
- 3010515547
- 3042200051
- 3014315560
- 3038611387
- 3027520350
- 3006673317
- 3032109
- 3012416077
- 1419489
- 2023739
- 3034669683
- 3015058854
- 3020468145
- 9611102
- 3010822231
- 3003169405
- 3006210673
- 9611283
- 1062671
- 1937141
- 3005809810
- 3044026004
- 3006538822
- 3011983031
- 9680718
- 3015309643
- 3010707607
- 1017768
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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