510(k) K930686
- Device
- MIDMARK SURGICAL LIGHTING SYSTEMS
- Applicant
- MIDMARK CORP.
- 510(k) number
- K930686
- Product code
- FSQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-07-30
- Date received
- 1993-02-10
- Regulation
- 878.4580
- Classification name
- Light, Surgical, Instrument
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- BRADLEY SEIDEN
- Address
- 60 Vista Dr. P.O. Box 286 Versailles OH US 45380 45380
FDA Registration Numbers#
- 3007123908
- 3006799849
- 3014388471
- 1221763
- 1061927
- 1037007
- 1222616
- 1834379
- 3004464325
- 1928237
- 3017815086
- 3022320321
- 3011050570
- 1066635
- 1526439
- 3008868758
- 3026312050
- 3043178571
- 3043177791
- 1218882
- 3017382141
- 3017553373
- 3016851779
- 3007143268
- 9681407
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FSQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K932139 | LIGHTED INTUBATION STYLET W/REPLACEABLE SHAFT | Aaron Medical Industries | 1993-07-30 |
| K922409 | ALM ILLUMINATOR SERIES LIGHT SYSTEM | Alm Surgical Equipment, Inc. | 1993-01-12 |
| K921848 | BFW WEHMERLITE IV-A FIBER OPTIC SURG. HEADLIGHT | Alm Surgical Equipment, Inc. | 1992-10-01 |
| K803067 | SURG-FLEX 10 LIGHT | Medical Products Development, Inc. | 1981-02-26 |
| K810018 | SURG-FLEX 5 SURGICAL LIGHT | Medical Products Development, Inc. | 1981-01-23 |
| K810019 | SURG-FLEX 15 SURGICAL LIGHT | Medical Products Development, Inc. | 1981-01-23 |
Legacy Summary#
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FDA Review#
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