510(k) K780608
- Device
- Ice Bag, Vinyl
- Applicant
- ABCO DEALERS, INC.
- 510(k) number
- K780608
- Product code
- KYR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-06-06
- Date received
- 1978-04-10
- Regulation
- 880.6050
- Classification name
- Bag, Ice
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- 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#
- 1000175697
- 3009544661
- 3030539818
- 3008754100
- 3008520652
- 9680411
- 3010952189
- 3015069920
- 3021244221
- 3017231740
- 3043654665
- 9613910
- 3007774549
- 300643947
- 9616086
- 3015177652
- 3011118556
- 3012466243
- 3010039589
- 3009068676
- 3013657868
- 3006707030
- 9616872
- 3010951384
- 3008559312
- 3016758972
- 3031184338
- 3032597205
- 3015214304
- 3015337116
- 3012314549
- 8022890
- 1649245
- 1043214
- 3008955719
- 3019798849
- 1043551
- 3015220641
- 3006542501
- 1062671
- 3010967704
- 3006537699
- 3036679484
- 2433012
- 3013046958
- 3007607706
- 9616914
- 3017619379
- 3010951382
- 3023395601
- 3019315696
- 3007838093
- 3033011342
- 3015977541
- 1422443
- 3017194442
- 3027157200
- 3006723155
- 3027500264
- 3030444262
- 2028253
- 3044150131
- 3009648765
- 2438391
- 2110420
- 3026885376
- 3014409525
- 3005621301
- 3008562183
- 3010595915
- 3001650535
- 3013443304
- 3014317667
- 3010508273
- 3005524530
- 3003965134
- 3010008676
- 3010409218
- 3005327291
- 3016928862
Source Documents#
510(k) summary PDF not indicated by FDA