510(k) K943871
- Device
- AQUAPLAST TIE DOWN DRESSING
- Applicant
- WFR/AQUAPLAST CORP.
- 510(k) number
- K943871
- Product code
- LZM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-09-30
- Date received
- 1994-08-08
- Regulation
- 878.4014
- Classification name
- Guard, Skin Graft
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOHN R KIRK
- Address
- P.O. Box 635 Wyckoff NJ US 07481 07481
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LZM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K885136 | GRAFT GUARD | Sorex Medical | 1989-02-06 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases