510(k) K800430
- Device
- OXIDE ANAEROBIC SYSTEM
- Applicant
- OXOID U.S.A., INC.
- 510(k) number
- K800430
- Product code
- JTM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-04-02
- Date received
- 1980-02-26
- Regulation
- 866.2120
- Classification name
- Anaerobic Box Glove
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3024716
- 3034605486
- 3009486864
- 1044031
- 3010198795
- 3024712919
- 3038637162
- 3026263452
- 2916932
- 3013522894
- 3013846070
- 3021550083
- 1523845
- 3013823481
- 3012314549
- 3025413691
- 3008973760
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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