510(k) K070048
- Device
- GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT
- Applicant
- Marian Medical, Inc.
- 510(k) number
- K070048
- Product code
- FCM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-03-15
- Date received
- 2007-01-03
- Regulation
- 876.5130
- Classification name
- Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- SANDRA WINKLER
- Address
- 319 Westport Dr. Louisville KY US 40207 40207
FDA Registration Numbers
- 3015173212
- 3014404707
- 1423537
- 3005669815
- 3011987967
- 3012445205
- 3017937889
- 3013188547
- 3014656749
- 3010220595
- 2648727
- 1043214
- 2320762
- 3011707784
- 2029015
- 1921846
- 3022518300
- 9611590
- 1055236
- 3006430057
- 9680787
- 3002993863
- 3004111573
- 3015142802
- 3018116884
- 1420054
- 3004727093
- 3008191244
- 1650927
- 3008806809
- 3014421917
- 9610849
- 3006673317
- 3015176887
- 2032112
- 9610694
- 2011171
- 8040607
- 2320961
- 1647149
- 3006082230
- 3017961114
- 3011137372
- 1018233
- 1054241
- 1480288
- 3005012805
- 9612030
- 3006542380
- 8040412
- 1928237
- 3007185216
- 3030087693
- 3009609358
- 3004122598
- 3004365956
Source Documents
510(k) summary PDF not indicated by FDA
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