510(k) K010217
- Device
- 4 PORT, 4 WAY STOPCOCK
- Applicant
- George Loo, MD
- 510(k) number
- K010217
- Product code
- FMG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-03-18
- Date received
- 2001-01-24
- Regulation
- 880.5440
- Classification name
- Stopcock, I.V. Set
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
Applicant Contact#
- Contact
- GEORGE LOO
- Address
- 9814 Curwood Pl. Beverly Hills CA US 90210 90210
FDA Registration Numbers#
- 3009211636
- 9615817
- 3032916632
- 3030447506
- 9680794
- 1060680
- 1625425
- 2011171
- 1061124
- 3012307300
- 3010041511
- 3010432890
- 9610847
- 9612152
- 3015173212
- 3012536737
- 3004111573
- 3033589330
- 3013683058
- 3013764800
- 2320762
- 2245270
- 1054241
- 9617594
- 1518293
- 1047429
- 9614279
- 2024024
- 1928237
- 3007344957
- 3006891665
- 3015309643
- 3002907620
- 1319639
- 3012798826
- 3006475220
- 1526863
- 1424263
- 1018470
- 3012261967
- 1043214
- 1030451
- 9616567
- 3007738736
- 1713468
- 3005012805
- 1423507
- 3013557562
- 1055236
- 1416980
- 3033536319
- 2523676
- 3017636737
- 1644312
- 2243072
- 9610849
- 2029275
- 8020616
- 2032112
- 1423537
- 3007017524
- 3006425876
- 3020778
- 8040700
- 3006950086
- 3015276780
- 3013188547
- 1047843
- 3003704957
- 1000324175
- 3013517171
- 1423662
- 2025816
- 1000563940
- 2022435
- 3010421104
- 3015085713
- 3012809732
- 1223004
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FMG#
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| K082110 | DUAL SYRINGE HOLDER | Surgin Surgical Instrumentation, Inc. | 2009-06-17 |
| K082836 | ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES | Icu Medical, Inc. | 2009-02-25 |
| K082106 | ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS) | Elcam Medical Acal | 2008-10-02 |
| K080077 | CLAVE STOPCOCK | Icu Medical, Inc. | 2008-02-13 |