510(k) K780422
- Device
- Pinwheel
- Applicant
- PROJECTS IN HEALTH
- 510(k) number
- K780422
- Product code
- GWY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-04-04
- Date received
- 1978-03-17
- Regulation
- 882.1750
- Classification name
- Pinwheel
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3014334038
- 9611112
- 3004168759
- 3005440795
- 3005809810
- 9710524
- 8043752
- 2435946
- 3019455
- 2249529
- 3011137372
- 8041151
- 3006554912
- 1000426080
- 3013358456
- 3009703496
- 1421879
- 9680304
- 1417592
- 3002834291
- 3004892425
- 3004001706
- 1836161
- 8040278
- 3014908171
- 3010041511
- 9614075
- 3035678069
- 3016170451
- 8010099
- 3011499367
- 8040233
- 9681622
- 3014615697
- 3003431869
- 3008770252
- 9611278
- 3008338766
- 9681540
- 3010288346
- 9611283
- 9680518
- 9680424
- 8010155
- 3003882387
- 3004598675
- 8040255
- 9612074
- 2246990
- 3003877407
- 3012226300
- 2432177
- 8030607
- 2434008
- 1720747
- 8043496
- 9611503
- 3003244954
- 3024088964
- 3003418325
- 3015512299
- 8040179
- 9610612
- 3015069921
- 3027556548
- 3002807115
- 3009513193
- 3013497507
Source Documents#
510(k) summary PDF not indicated by FDA