510(k) K841116
- Device
- MOBILE OPHTHALMIC OPERATING TABLE
- Applicant
- SURGI-QUIP INC.U
- 510(k) number
- K841116
- Product code
- FWX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-05-09
- Date received
- 1984-03-15
- Regulation
- 878.4950
- Classification name
- Table, Operating-room, Mechanical
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
FDA Registration Numbers#
- 3006467297
- 3003574554
- 3009715914
- 9680168
- 3006897996
- 9613910
- 3007123908
- 3008110533
- 3011910987
- 3002925671
- 3003923584
- 3008610343
- 3008881803
- 3005180920
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FWX #
Legacy Summary#
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FDA Review#
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