510(k) K885136
- Device
- GRAFT GUARD
- Applicant
- SOREX MEDICAL
- 510(k) number
- K885136
- Product code
- LZM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-02-06
- Date received
- 1988-12-15
- Regulation
- 878.4014
- Classification name
- Guard, Skin Graft
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- REED F WINTERTON
- Address
- 2955 S. Main St. Salt Lake City UT US 84115 84115
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LZM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K943871 | AQUAPLAST TIE DOWN DRESSING | Wfr/Aquaplast Corp. | 1994-09-30 |
Legacy Summary#
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FDA Review#
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