510(k) K062112
- Device
- SUNMED FOLEY CATHETERS
- Applicant
- Sunmed, Inc.
- 510(k) number
- K062112
- Product code
- EZL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-06-04
- Date received
- 2006-07-24
- Regulation
- 876.5130
- Classification name
- Catheter, Retention Type, Balloon
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- ARTHUR WARD
- Address
- 962 Allegro Ln. Appollo Beach FL US 33572 33572
FDA Registration Numbers
- 3000247873
- 3015173212
- 3012050423
- 1423537
- 3011987967
- 3014656749
- 1423662
- 3007289408
- 3031190571
- 3010400865
- 8022978
- 3009057691
- 3015997711
- 3003537036
- 3027547323
- 3009086335
- 3016998661
- 2032112
- 3002907620
- 9616088
- 2011171
- 1018233
- 3029906222
- 1054241
- 1928237
- 3012833053
- 3015337348
- 3043051314
- 3000268902
- 1721686
- 3027301746
- 3008959444
- 3000308637
- 9610711
- 3010220595
- 3030089838
- 3000247987
- 3011707784
- 2029015
- 3014650073
- 1921846
- 3005483737
- 3003903031
- 9611590
- 1055236
- 3007798534
- 3004111573
- 1825146
- 3027553380
- 3013369910
- 3008806809
- 9611712
- 3030970103
- 3003814961
- 1649518
- 3004070478
- 1820334
- 9612030
- 1061124
- 2432320
- 1526534
- 3005012805
- 3003965134
- 3021468326
- 3006621386
- 3005515211
- 3010173425
- 3016904853
- 1043214
- 2320762
- 3003477135
- 3014637079
- 1058397
- 3016738724
- 3012104670
- 3022518300
- 3013298431
- 3016618143
- 1417592
Source Documents
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