510(k) K925630
- Device
- ELASTOPLAST HEAT PLASTER
- Applicant
- BEIERSDORF, INC.
- 510(k) number
- K925630
- Product code
- MLX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-02-25
- Date received
- 1992-11-06
- Regulation
- 510(k) Premarket Notification
- Classification name
- Pad, Medicated, Adhesive, Non-electric
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KENNETH M NICOLL
- Address
- 360 Martin Luther King Dr. P.O. Box 5529 Norwalk CT US 06856 06856
FDA Registration Numbers#
- 1832415
- 3010852191
- 3038294422
- 3027694073
- 3011564440
- 3003772414
- 9616086
- 3012446970
- 3004203811
- 3034204844
- 3029992391
- 3013284090
- 3026312365
- 3010402752
- 3006537699
- 3030343924
- 9611558
- 3042129703
- 3013738756
- 3017936723
- 3020978012
- 3014325813
- 3010343052
- 3038276093
- 3006546131
- 3042193295
- 3017178493
- 9616868
- 3014948462
- 3025384289
- 3022066208
- 3016831175
- 3020978007
- 3010400996
- 3043177693
- 3030979187
- 3042194239
- 3011919098
- 3008212609
- 3023143124
- 3011077581
- 3010008676
- 3017152329
- 3017429279
- 3006850006
- 3015562776
- 3013856565
- 3015501220
- 3030539818
- 3004006265
- 3017618922
- 3013019295
- 3013865802
- 3016171836
- 3017207289
- 3017435733
- 3004524854
- 3017304966
- 3006654680
- 3012316249
- 3014344342
- 3009668937
- 3028172072
- 3004412274
- 3038295706
- 9615330
- 3016452327
- 3030519475
- 3008959444
- 3003751839
- 3013579894
- 3009437400
- 1528161
- 3004146401
- 1043899
- 3011526963
- 3013601329
- 3017222105
- 3002743035
Source Documents#
Legacy Summary#
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FDA Review#
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