510(k) K940903
- Device
- TONSIL SPONGE, GAUZE DISSECTOR, CYLINDRICAL SPONGES
- Applicant
- MEDICAL INSIGHTS, INC.
- 510(k) number
- K940903
- Product code
- KBM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-04-14
- Date received
- 1994-02-24
- Regulation
- 874.4420
- Classification name
- Dissector, Tonsil
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROBERT J CARICATO
- Address
- 193 Whitehall Ave. Mystic CT US 06355 06355
FDA Registration Numbers#
- 3004001706
- 3009542933
- 1926681
- 3014615697
- 8010273
- 2529846
- 1032347
- 3004998166
- 3003644849
- 9680735
- 3013247477
- 9680515
- 3003418325
- 3011371465
- 1836161
- 9613926
- 1923569
- 9610612
- 1057946
- 3013497507
- 3010455030
- 3014334038
- 3003431869
- 3023657851
- 3022862651
- 3029082594
- 2916714
- 3008711893
- 9611112
- 9612074
- 3010726901
- 9610773
- 3001408183
- 8010269
- 2431166
- 9611283
- 1313525
- 3036795921
- 3009255580
- 3006847952
- 9680518
- 9610905
- 8010300
- 3011050570
- 2242656
- 8030607
- 9612075
- 8040881
- 3005067367
- 3015895045
- 8010099
- 1048735
- 3015972835
- 3011137372
- 1932180
- 9680519
- 8010155
- 3010041511
- 3005440795
- 8040278
- 3003244954
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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