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
- 3031582434
- 3017264244
- 3023395601
- 8043965
- 3010805190
- 3011118556
- 3010039589
- 3013632692
- 2110420
- 3009303243
- 3006847952
- 2648727
- 3008559312
- 3009544661
- 9616872
- 3006416350
- 3015727296
- 3006723155
- 3010595915
- 8043323
- 3004496839
- 2432177
- 1043551
- 3004905643
- 3009750712
- 3034669683
- 9710567
- 3008412545
- 3004615451
- 3012466243
- 3016928862
- 2433012
- 3012314549
- 300643947
- 3010453313
- 3008676146
- 1720839
- 3043654665
- 3001650535
- 3007479164
- 3005951403
- 3009648765
- 3014317667
- 3017619379
- 3036679484
- 3023339256
- 3009308092
- 3010008676
- 3014620201
- 3032597205
- 3013443304
- 8030607
- 3011050481
- 3021244221
- 3012034017
- 3010967704
- 3015344405
- 3014982528
- 3033011342
- 3015977541
- 3014421917
- 3007539307
- 1043214
- 3006707030
- 3008955719
- 3012241417
- 3014747754
- 3008562183
- 3014982318
- 9616914
- 3008808082
- 2028253
- 3014146451
- 3010508273
- 1060680
- 3015337116
- 3010872396
- 3017962065
- 3007853907
Source Documents#
510(k) summary PDF not indicated by FDA