510(k) K900208
- Device
- ZEROWET SPLASHIELD
- Applicant
- ZEROWET SPLASHIELD
- 510(k) number
- K900208
- Product code
- KYZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-09-04
- Date received
- 1990-01-17
- 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
- STAMLER, MD
- Address
- 1715 Via El Prado P.O. Box 7000-16 Redondo Beach CA US 90277 90277
FDA Registration Numbers#
- 3013506123
- 9610825
- 3005593675
- 3031700059
- 8040537
- 3008693658
- 3045058049
- 3013630887
- 1526534
- 3011088743
- 3013496867
- 3005809810
- 3010380518
- 3012972093
- 1915484
- 3014637079
- 3021639773
- 3010419931
- 3010202439
- 3011182134
- 3010621964
- 2381321
- 3006673317
- 3018074706
- 3003887292
- 1649395
- 1123137
- 3017618922
- 9710020
- 3002808270
- 1250045
- 9610617
- 3001620590
- 3016851379
- 3016758972
- 3004416208
- 3012002722
- 3035678069
- 1217805
- 1060680
- 1721504
- 3009742443
- 3015337348
- 3010683450
- 3005934752
- 3011689956
- 3038294399
- 3024088964
- 8041151
- 3004468406
- 1055236
- 3005327291
- 3024999438
- 3012314549
- 3017636737
- 8043685
- 3012416077
- 3002579136
- 1423625
- 3026844237
- 3025428426
- 3009307523
- 1216677
- 3012494290
- 2523676
- 3044994756
- 3042200051
- 3003877407
- 3034667025
- 3003799587
- 3010337881
- 9681260
- 9680222
- 3004001706
- 1719513
- 1287329
- 3023174629
- 1423537
- 2023739
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 |
| 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 |
Legacy Summary#
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FDA Review#
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