510(k) K062061
- Device
- URASSIST
- Applicant
- PREFERRED MEDICAL DEVICES, INC.
- 510(k) number
- K062061
- Product code
- NZU
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-10-05
- Date received
- 2006-07-20
- Regulation
- 876.5250
- Classification name
- Collector, Urine, Powered, Non Indwelling Catheter
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- PENELOPE GRECO
- Address
- 8 Gray Lodge Rd. Kittery ME US 03904 03904
FDA Registration Numbers#
- 3011120183
- 3010193531
- 3038139564
- 3013557562
- 3009425497
- 3003755374
- 3023230882
- 1018233
- 3007309299
- 8040607
- 2518417
- 3011020307
- 1419181
- 1417592
- 3011802696
- 3019502344
- 3032798406
- 3009656988
- 3013484413
- 3005105203
- 3012944064
- 3022121576
- 2087033
- 9611590
- 3012421607
- 3013041594
- 3009632672
- 3014437893
- 3040278138
- 3030394731
- 3010580321
- 3014498861
- 3013524793
- 3040388410
- 9616067
- 3004527595
- 3014615175
- 1220351
- 3016734231
- 9614977
- 3011533719
Source Documents#
Legacy Summary#
summary
FDA Review#
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