510(k) K971498
- Device
- APPLIED MEDICAL LAPAROSCOPIC GUIDEWIRE
- Applicant
- APPLIED MEDICAL RESOURCES
- 510(k) number
- K971498
- Product code
- EZB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-05-05
- Date received
- 1997-04-25
- Regulation
- 876.5130
- Classification name
- Stylet For Catheter, Gastro-urology
- 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
- HOWARD V ROWE
- Address
- 26051 Merit Cir. Bldg. 104 Launa Hills CA US 92653 92653
FDA Registration Numbers#
- 3010155661
- 3004134316
- 1651252
- 2183744
- 3007695959
- 3004579081
- 3017210488
- 1313046
- 3003418325
- 1836161
- 1923569
- 2521453
- 3014334038
- 9611610
- 3004215117
- 9617744
- 3010273872
- 8040278
- 2124215
- 9611590
- 3005099803
- 3002807314
- 3005809810
- 3005987240
- 9613079
- 1825146
- 1000121056
- 3012267976
- 3008988055
- 2027111
- 8030607
- 9616067
- 3009051888
- 3013666336
- 1820334
- 3006082230
- 3011137372
- 2126666
- 1018233
- 3009763019
- 9681477
- 9616246
- 3004608878
- 9681260
- 3004859241
- 3001644167
- 3010041511
- 3004365956
Source Documents#
Other 510(k) Records For Product Code EZB #
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases