510(k) K870781
- Device
- ACROMED WALLIE-HEINIG DISECTOR/ELEVATORS
- Applicant
- BUCKMAN CO., INC.
- 510(k) number
- K870781
- Product code
- GEG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-03-09
- Date received
- 1987-02-26
- Regulation
- 878.4800
- Classification name
- Elevator, Surgical, General & Plastic Surgery
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAVID W SCHLERF
- Address
- 921 Calle Verde Martinez CA US 94553 94553
FDA Registration Numbers#
- 1219518
- 3006561161
- 9616250
- 3004049923
- 3003694247
- 8010372
- 3002834291
- 1051526
- 8010257
- 1066741
- 8040278
- 3027262786
- 3010041511
- 9680515
- 3008338766
- 3003988575
- 3015177648
- 1720747
- 1315756
- 1222773
- 3010055973
- 3011600579
- 3008114965
- 8010528
- 3004215117
- 3023657851
- 3024988980
- 9680837
- 3015451162
- 1056350
- 3004608878
- 1032347
- 3022320321
- 3043355002
- 3007648354
- 9611274
- 9681622
- 3005083075
- 9610621
- 3005621335
- 2437731
- 2242450
- 3005440795
- 1930126
- 3003431869
- 3013875765
- 3011137372
- 3008711893
- 3001408183
- 8010379
- 3005809810
- 8010890
- 3043047788
- 8010871
- 3005641619
- 1424478
- 3006554912
- 1935627
- 8010697
- 3002808270
- 3017352116
- 3016069968
- 8010155
- 3005061536
- 3006059917
- 1221934
- 3009513193
- 3008797953
- 9611461
- 8044098
- 3006380247
- 2087382
- 3006487092
- 3029082594
- 1818910
- 3007507973
- 9680519
- 9613079
- 9614062
- 1422507
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GEG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K891894 | ELEVATORS-COTTLE,MCKENTY,GOLDMAN,JOSEPH,CONVERSE | Zinnanti Surgical Instruments, Inc. | 1989-04-12 |
| K891899 | ELEVATORS, VARIOUS TYPES | Zinnanti Surgical Instruments, Inc. | 1989-04-12 |
| K890365 | SEPTUM ELEVATOR | Kinetic Medical Products | 1989-02-03 |
| K890230 | LIGATURE NEEDLES | Kinetic Medical Products | 1989-01-27 |
| K890253 | SURGICAL ELEVATOR | Kinetic Medical Products | 1989-01-27 |
| K872491 | 1.1 TWIST DRILLS AND 1.2 CORTICAL DRILLS | Micro-Aire Surgical Instruments, Inc. | 1987-07-16 |
| K870591 | ELEVATOR, COBB SPINAL | Military Engineering, Inc. | 1987-02-26 |
| K870126 | FEMUR WRENCH | Orthopedic Systems, Inc. | 1987-02-03 |
| K864421 | RAYLOR(TM) PERIOSTEAL ELEVATORS | Cedar Surgical, Inc. | 1986-11-26 |
| K834176 | H.R. JAKOBI SURG. INSTRUMENTS 40/41 | Imm Enterprises , Ltd. | 1984-01-27 |
| K781449 | HARRINGTON SPINAL ELEVATOR | Orthopedic Equipment Co., Inc. | 1978-09-27 |
Legacy Summary#
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FDA Review#
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