510(k) K926288
- Device
- SOM 6VI (SURGICAL OPERATING MICROSCOPE)
- Applicant
- JEDMED INSTRUMENT CO.
- 510(k) number
- K926288
- Product code
- FSO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-10-12
- Date received
- 1992-12-14
- Regulation
- 878.4700
- Classification name
- Microscope, Surgical, General & Plastic Surgery
- 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
- CRAIG RAPP
- Address
- 6096 Lemay Ferry Rd. St.Louis MO US 63129 63129
FDA Registration Numbers#
- 3007123908
- 3025436467
- 3005527296
- 3003851947
- 3005755367
- 2127132
- 3014388471
- 3010202439
- 2020550
- 9615010
- 3008590661
- 1836161
- 3014683120
- 8010573
- 3003974370
- 1054713
- 3006252153
- 3031700059
- 2916714
- 3013351723
- 3003591740
- 3015180671
- 3009598746
- 1820334
- 3001644167
- 1645452
- 3013403214
- 3013154160
- 3009560832
- 3029755582
- 1000204638
- 8030607
- 3014059828
- 3006543022
- 3014644251
- 3042172882
- 3009340886
- 3032734659
- 1528142
- 9610612
- 3005273623
- 3010242141
- 3005527904
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FSO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K942304 | MICROFLEX | Moeller Microsurgical, Inc. | 1994-06-13 |
| K941399 | OPERATING MICROSCOPE AA OM 10 | Appasamy Associates (U.S.A.), Inc. | 1994-04-22 |
| K920689 | DEEMED MSS -- MICROSCOPE SUPPORT SYSTEM | Deemed, Inc. | 1993-11-12 |
| K931303 | WOODLYN OPERATION MICROSCOPE | Woodlyn, Inc. | 1993-06-25 |
| K926513 | MOLLER-WEDEL OPERATING MICROSCOPE | Moeller Microsurgical, Inc. | 1993-06-22 |
| K910357 | SOM 6V | Jedmed Instrument Co. | 1991-02-19 |
| K902076 | J2 MICROSCOPE | Jedmed Instrument Co. | 1990-08-01 |
| K874241 | OPMI MD SURGICAL MICROSCOPE | Carl Zeiss, Inc. | 1987-12-23 |
| K822562 | ODONTO-SCOPE | Treace Medical, Inc. | 1982-10-06 |
| K822181 | BINOCULAR OPER. MICROSCOPES & ACCESSOR | Kelleher Corp. | 1982-08-27 |
| K822015 | BINOCULAR OPERATING MICROSCOPES AND | Kelleher Corp. | 1982-07-30 |
| K802713 | FMS-02 FLOOR-UNIT MODEL MICROSCOPE | Jedmed Instrument Co. | 1980-11-19 |
| K801314 | VOCON MODEL VC526 | Teknar, Inc. | 1980-09-09 |
| K791280 | OPERATION MICROSCOPE SOM 1 | Elmed, Inc. | 1979-07-24 |
Legacy Summary#
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FDA Review#
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