510(k) K935569
- Device
- INSTANT HOT OR COLD DISPOSABLE PACK
- Applicant
- Cryopak Industries, Inc.
- 510(k) number
- K935569
- Product code
- IMD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-03-07
- Date received
- 1993-11-18
- Regulation
- 890.5710
- Classification name
- Pack, Hot Or Cold, Disposable
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- MIKE KENDRA
- Address
- P.O. Box 80807 Delta, British Columbia Canada CA V5H-3Y1 V5H-3Y1
FDA Registration Numbers
- 1450662
- 3015220641
- 3023341288
- 3030488262
- 3012314549
- 3013735158
- 9615433
- 3038103734
- 3006210673
- 3005621729
- 3015277818
- 3030671612
- 2110420
- 3015526491
- 1216677
- 3029952416
- 3010182295
- 3016170587
- 3007865243
- 3015392301
- 3008174904
- 1423537
- 3008676146
- 3017299525
- 3006943846
- 3008742818
- 3010675856
- 3012711490
- 3003887292
- 3042896810
- 2214133
- 8030358
- 9680689
- 3010370474
- 3031589938
- 3014632167
- 3044466317
- 3005083505
- 3017591220
- 3008386507
- 3005533873
- 3031233916
- 3031595576
- 3016050930
- 3008808082
- 3012480535
- 9680284
- 3016816791
- 3013034812
- 3023917
- 3004993527
- 3008384335
- 2415591
- 3008693666
- 1034116
- 3042276434
- 3008774899
- 3020978033
- 3016761372
- 3004605321
- 3012034017
- 3014683120
- 3038718579
- 3005739529
- 3005343641
- 9021987
- 3021590259
- 1032347
- 3016778706
- 3038624153
- 3015375647
- 3008216220
- 3011118556
- 3006455037
- 3015339737
- 2438774
- 3038637162
- 3038199417
- 3016426842
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON
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