510(k) K012320
- Device
- POWERPRO BATTERY SYSTEM
- Applicant
- LINVATEC CORP.
- 510(k) number
- K012320
- Product code
- HAB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-10-19
- Date received
- 2001-07-23
- Regulation
- 878.4820
- Classification name
- Saw, Powered, And Accessories
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- LAURA D SENEFF
- Address
- 11311 Concept Blvd. Largo FL US 33773 33773
FDA Registration Numbers#
- 3007366790
- 3016851379
- 3007279848
- 1220246
- 3002579136
- 1818910
- 3007958831
- 8010379
- 3038503932
- 3015967359
- 3005067367
- 9680741
- 3032391
- 1219602
- 3010097171
- 1836161
- 3006183537
- 3011300255
- 3015231789
- 2025102
- 9681479
- 1020279
- 3022320321
- 2022435
- 2916714
- 3007305485
- 9611253
- 8031000
- 3016050940
- 3013055499
- 1526350
- 3018101388
- 9680424
- 1220477
- 1226544
- 1054811
- 3013011598
- 1422375
- 1017294
- 3012494290
- 8030607
- 8043496
- 3031240334
- 3010331645
- 1643264
- 3010849408
- 1055890
- 3009125070
- 3014207283
- 1828464
- 3005061536
- 9610612
- 3012447612
- 9680718
- 3008744062
- 3013893019
- 3003604053
- 3008650117
- 3015972835
Source Documents#
Other 510(k) Records For Product Code HAB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K935517 | SNAP STERNUM SAW | Surgiquip, Inc. | 1994-03-10 |
Legacy Summary#
summary
FDA Review#
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