510(k) K834127
- Device
- INSTRUMENT TIP PROTECTION COVERS
- Applicant
- DEVON INDUSTRIES, INC.
- 510(k) number
- K834127
- Product code
- LXZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-02-17
- Date received
- 1983-11-29
- Regulation
- 878.4800
- Classification name
- Guard, Instrument
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- 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#
- 3036756245
- 2248030
- 3010314800
- 3012114684
- 3031841433
- 3027483183
- 3030626857
- 3042272797
- 1932180
- 3010419931
- 3013557562
- 3008004502
- 3031572059
- 3000187060
- 3033509898
- 3025603301
- 3036504234
- 1313525
- 9610612
- 3015895045
- 2953359
- 3038613128
- 2431166
- 1722511
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LXZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K955463 | GRIP-A-BOOTS | Sil-Med Corp. | 1996-01-23 |
Legacy Summary#
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FDA Review#
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