510(k) K780599
- Device
- Syringe, Ear & Ulcer
- Applicant
- ABCO DEALERS, INC.
- 510(k) number
- K780599
- Product code
- KCP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-04-19
- Date received
- 1978-04-10
- Regulation
- 874.5220
- Classification name
- Syringe, Ent
- Medical specialty
- Ear, Nose, Throat
- Review panel
- Ear, Nose, Throat
- 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#
- 3010339057
- 3008338766
- 3015393204
- 8043752
- 1836161
- 3005202235
- 9611503
- 3020751316
- 3042624965
- 3002090132
- 3003759558
- 1526854
- 3008281139
- 1056350
- 3008902714
- 3006411563
- 8040278
- 3011625373
- 8040263
- 1037752
- 3004111573
- 3005770514
- 3009513193
- 3003905396
- 3026848699
- 3011499367
- 1317900
- 9680954
- 3017635043
- 3006610790
- 3002807115
- 9680002
- 3003877407
- 3013784566
- 8040881
- 8010418
- 3011310592
- 9611283
- 1421879
- 3003407244
- 3005418739
- 9611112
- 3005809810
- 3009104075
- 3001297506
- 9680518
- 3008174904
- 3015895045
- 3007681502
- 3015512299
- 3012226300
- 2183416
- 9610621
- 3004001706
- 9610612
- 3002769835
- 3006059835
- 3010041511
- 3013557562
- 3009124884
- 8030607
- 3012896103
- 3016170302
- 8040884
- 3003244954
- 9613083
- 3003882387
- 3007703436
- 3008770252
- 3014334038
- 3011209790
- 3045855232
- 3010353847
- 9615834
- 3002834291
- 3030539818
- 1420054
- 3029082594
- 8010730
- 3003418325
Source Documents#
510(k) summary PDF not indicated by FDA