510(k) K803200
- Device
- IRRIGATION SET W/BULB SYRINGE
- Applicant
- WALPAK CO.
- 510(k) number
- K803200
- Product code
- KYZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-01-21
- Date received
- 1980-12-17
- 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#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3006730167
- 3013557562
- 1061124
- 1060680
- 3005934752
- 3025337868
- 3009888344
- 3032109
- 3006610790
- 3036722184
- 3006210673
- 3005418739
- 3017770710
- 1719513
- 3010380518
- 9614279
- 3015238043
- 1416980
- 3017429279
- 8040537
- 3005034064
- 1420054
- 2023739
- 3009746061
- 3009937681
- 2433012
- 1423537
- 3009742443
- 3006673317
- 2183650
- 3012507533
- 1055236
- 3007681502
- 2084346
- 3008502431
- 3001124136
- 3004941127
- 3042200051
- 3010177471
- 1721504
- 2648727
- 9617744
- 3005202235
- 1054241
- 8010298
- 3005515211
- 3013517171
- 3008719222
- 3014334038
- 3004416208
- 3005273623
- 9614062
- 3006552462
- 3010707607
- 3003799587
- 3005670221
- 3006181312
- 3018074706
- 3015974593
- 3007703293
- 3006542380
- 9610612
- 3026848699
- 3043051314
- 3010822231
- 3045816907
- 1419489
- 1064619
- 3005669815
- 1417592
- 1422443
- 1824619
- 3008412545
- 9681260
- 2028807
- 3006542501
- 3012445205
- 3009308092
- 1422634
- 1721676
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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