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#
- 3007597038
- 3021680161
- 3004168759
- 9680954
- 3003882387
- 1928237
- 3001297506
- 3002769835
- 3016170302
- 3009104075
- 3003905396
- 3038718579
- 3017635043
- 3011310592
- 3015512299
- 3008936260
- 9614075
- 9615834
- 3039414397
- 3004608878
- 3011209790
- 3003836856
- 9611112
- 2529846
- 3006610790
- 3002834291
- 9613083
- 1420054
- 3006181312
- 3015393204
- 3015821396
- 3005809810
- 1317900
- 3012226300
- 3045855232
- 3044819802
- 3020751316
- 9610612
- 3003431869
- 9680002
- 8030607
- 9680304
- 3001620590
- 3008808049
- 3004598675
- 3011137372
- 3012187635
- 3003407244
- 3008650974
- 3003759558
- 1932180
- 3008281139
- 3003956316
- 1926681
- 3008174904
- 3004892425
- 3003244954
- 1037752
- 9680837
- 3021013132
- 2431166
- 3005418739
- 1929340
- 2183416
- 3019315696
- 3004111573
- 8040263
- 3006411563
- 8040884
- 3043725362
- 1000137876
- 3004001706
- 3029082594
- 3008338766
- 3010041511
- 3012416077
- 3022862651
- 3035878921
- 9610621
- 3002090132
Source Documents#
510(k) summary PDF not indicated by FDA