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#
- 9680794
- 3008384335
- 3016758972
- 3012316249
- 3030525551
- 3013496867
- 3011689956
- 9616250
- 3018781093
- 3008280537
- 2246990
- 3015225571
- 3031915926
- 3005841027
- 1526534
- 3010400367
- 3017385563
- 3001124136
- 9611503
- 3013057712
- 1030451
- 3017429279
- 2220100
- 2433012
- 1418479
- 3018074706
- 3025337868
- 3011805315
- 3019798849
- 1220477
- 1043646
- 3005271071
- 3004111573
- 1419489
- 3007456622
- 3003877407
- 8010418
- 1825146
- 1017768
- 1450662
- 3005809810
- 3032109
- 3006673317
- 3004941127
- 2183416
- 9610621
- 9610612
- 8041151
- 3025428426
- 3013557562
- 3009499159
- 3031233007
- 3030089798
- 3013506123
- 3014252464
- 3007682555
- 3027473313
- 3014312726
- 3003244954
- 3012445205
- 1062671
- 3006730167
- 3036722184
- 9616246
- 3033589330
- 3016851379
- 1928237
- 3005905524
- 3015173212
- 1058726
- 3038356900
- 1720929
- 3003799587
- 3014315560
- 3015745029
- 3008936260
- 3016872092
- 3005987240
- 3010822231
- 3030733800
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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