510(k) K943386
- Device
- CPR MICROMASK
- Applicant
- PLASCO, INC.
- 510(k) number
- K943386
- Product code
- LYM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-02-21
- Date received
- 1994-07-13
- Regulation
- 510(k) Premarket Notification
- Classification name
- Device, Cpr Assist
- 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
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- GARY S BOTSFORD
- Address
- 3849 Swanson St. Gurnee IL US 60031 60031
FDA Registration Numbers#
- 3008264111
- 3008384335
- 3008261717
- 9710391
- 2518436
- 3014126909
- 3001313714
- 9710644
- 3006534321
- 2022648
- 3013226
- 9616567
- 3005621729
- 3003674698
- 3015191173
- 3030455652
- 9610861
- 3016450032
- 8043316
- 3006783791
- 2020676
- 3012711490
- 3017406698
- 3004993040
- 3025413691
- 3015745029
- 9681409
- 3004056932
- 3021039857
- 3011647251
- 3001106688
- 3012762174
- 3001204077
- 9612374
- 3011767915
- 3005587132
- 2028807
- 3010402691
- 3009512503
- 2085602
- 3003887292
- 1250045
- 3015781296
- 3010934856
- 3031288561
- 2030745
- 3020777588
- 9681848
- 1025972
- 9611451
- 3015422337
- 8030673
- 2431014
- 3012307300
- 3006157842
- 3011137372
- 3011529314
- 9616354
- 3020460367
- 3014527907
- 3003902679
- 3002807267
- 1924066
- 1314417
- 2183615
- 3010452651
- 3012034017
- 3011185837
- 3004365956
- 1526863
Source Documents#
Legacy Summary#
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FDA Review#
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