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#
- 3008950965
- 3013627744
- 3027509245
- 3026312077
- 3045752480
- 3018109879
- 3020994856
- 3048342100
- 3010097863
- 1832894
- 3012341715
- 3046007041
- 3040278125
- 3008970204
- 3014139817
- 3013865802
- 3029998436
- 3033920060
- 3030343924
- 3004126239
- 3014680784
- 3005273623
- 3014144875
- 3007543044
- 3010487117
- 3002849858
- 3013284090
- 3017618922
- 3012639937
- 3017450375
- 3002743035
- 3010724743
- 3004203811
- 3017304966
- 3006850006
- 3017178493
- 3019623342
- 3025384289
- 3007790958
- 3011407851
- 3005037196
- 3043013796
- 3013566770
- 3016087653
- 3027327500
- 3013601329
- 3017858989
- 3006654680
- 3026312365
- 3043105161
- 1422443
- 3010027944
- 9616086
- 1222304
- 3007075140
- 3004668337
- 3009227834
- 3012316249
- 3010008676
- 3038636181
- 3015562776
- 3035878914
- 3043149162
- 3025806468
- 9616933
- 3030019986
- 3017103444
- 3009156060
- 3013738756
- 3021656665
- 3030539818
- 3038632739
- 3011919098
- 3004524854
- 3042284335
- 3009641282
- 3042268484
- 3045925755
- 3018448099
Source Documents#
Legacy Summary#
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FDA Review#
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