510(k) K922288
- Device
- HOLDER, PEDIATRIC POSITION
- Applicant
- YAMASHITA AND HEMSLEY BUSINESS TRUST
- 510(k) number
- K922288
- Product code
- BWN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-02-10
- Date received
- 1992-05-15
- Regulation
- 878.4950
- Classification name
- Table And Attachments, Operating-room
- 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
- KUNIO YAMASHITA
- Address
- 2834 Rosewood St. Medford OR US 97504 97504
FDA Registration Numbers#
- 3016110967
- 3016050940
- 1450428
- 3007417753
- 9611102
- 3033589330
- 3007744192
- 1836161
- 3020767943
- 3015528095
- 3003102481
- 1825034
- 3017637606
- 3031563141
- 3037012186
- 3030441550
- 8010652
- 1043572
- 3014739961
- 3005157379
- 3030192580
- 8010273
- 3012329552
- 3017911818
- 3008769756
- 3015806723
- 3008627763
- 3011277660
- 3002579136
- 3014421917
- 3013700547
- 3002858762
- 3007913191
- 3029970239
- 3010625818
- 3040265659
- 3006498370
- 3009539885
- 3021374638
- 3043654660
- 3011092264
- 3019856155
- 3006950086
- 1647149
- 3012536737
- 3003890514
- 3006098219
- 2182318
- 3012818475
- 3020188747
- 3019269298
- 9680168
- 2030380
- 3013685983
- 3013408788
- 3019502344
- 9616088
- 1721504
- 3013660200
- 3016851379
- 3012619193
- 3012447612
- 3014334038
- 3015384437
- 1412854
- 3005809810
- 3007836437
- 3016590299
- 3027815
- 3005748481
- 9616096
- 3026133770
- 3006467297
- 3011215096
- 3009251316
- 8010379
- 3010331645
- 3014004349
- 1722447
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code BWN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K942699 | AIRFRAME SURGICAL DRAPE SUPPORT | Alpha Surgical, Inc. | 1994-07-13 |
| K935441 | INFINITECH BREATH EZ | Infinitech, Inc. | 1994-02-07 |
| K925005 | ISI SELF-SUPPORTING ARM | Instrumentation Specialties, Inc. | 1993-04-29 |
| K910783 | SHAMPAINE MODEL 3800 OR MURANAKA MODEL OR-604M | Smith & Nephew Equipment Group | 1991-04-02 |
| K902865 | BAUMER SURGICAL TABLE | Sds Dental, Inc. | 1990-09-10 |
| K884558 | IOP ADJUSTABLE STIRRUP | Mend Technologies, Inc. | 1988-11-17 |
| K875291 | SPINAL SURGERY FRAME | T. Korossurgical Instruments Corp. | 1988-01-22 |
| K873272 | ENDOSCOPY TABLE 1532 ENDOSTAR | Stierlen-Maquet AG | 1987-09-08 |
| K860177 | ALLEN UNIVERSAL STIRRUP | Edgewater Medical Equipment Systems | 1986-02-11 |
| K852332 | TABLE ACCESSORIES, OPERATING ROOM | Scholten Surgical Instruments, Inc. | 1985-07-02 |
| K843121 | GUIDE TO THE KNEE | Dyonics, Inc. | 1984-09-07 |
| K832340 | OPERATING ROOM TABLES HYDRAULIC | Kamiya Tsusan Kaisha, Ltd. | 1983-08-12 |
| K823772 | AMSCO ORTHOGRAPHIC 2 TABLE | American Sterilizer Co. | 1983-01-14 |
| K820574 | ARMBOARD FOR INTRAVENOUS ANES. IN DENTAL | David Simmonds Co., Inc. | 1982-03-23 |
| K812395 | ARTHRO-PREP REST W/STAND | Northwest Surgical Concepts, Inc. | 1981-11-20 |
Legacy Summary#
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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