510(k) K013133
- Device
- NORDIX INC RECHARGEABLE BATTERY PART NUMBER 2116
- Applicant
- Nordix, Inc.
- 510(k) number
- K013133
- Product code
- MOQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-11-13
- Date received
- 2001-09-19
- Regulation
- 878.4820
- Classification name
- Battery, Replacement, Rechargeable
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
Applicant Contact#
- Contact
- MARIAN LISAK
- Address
- 6831 N. 21st Ave. Phoenix AZ US 85015 85015
FDA Registration Numbers#
- 3011774865
- 3015967359
- 1220908
- 2027062
- 3004464325
- 3013421741
- 3010393565
- 2029275
- 1836161
- 9610612
- 1057946
- 3006438441
- 3008812560
- 8031000
- 1526350
- 3004049923
- 1000491390
- 3010849408
- 2916714
- 3007901088
- 3013002920
- 1045834
- 9617840
- 8030965
- 3009417901
- 3007305485
- 3007190523
- 3009381954
- 3006017180
- 3013710866
- 9610905
- 3010303097
- 9680424
- 3042927788
- 3008709738
- 2020601
- 3008793310
- 8030607
- 3007997036
- 2183890
- 3013055499
- 3011137372
- 3012421607
- 3015399803
- 3005521864
- 2024312
- 3020306671
- 3034676720
- 1017294
Source Documents#
510(k) summary PDF not indicated by FDA