510(k) K855132
- Device
- SHAVE PREP TRAY
- Applicant
- DYNAREX CORP.
- 510(k) number
- K855132
- Product code
- MDM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-01-24
- Date received
- 1985-12-23
- Regulation
- 878.4800
- Classification name
- Instrument, Manual, Surgical, General Use
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARVIN D SCHATTNER
- Address
- One International Blvd. Brewster NY US 10509 10509
FDA Registration Numbers#
- 9614069
- 3038776593
- 9680620
- 1034876
- 2084346
- 3007344957
- 1422634
- 9617544
- 3005099803
- 3006395932
- 3011307621
- 1531174
- 2020550
- 3004727197
- 3008386507
- 3015895045
- 3001239363
- 9616250
- 3034669683
- 1836161
- 9611281
- 3043007473
- 9680718
- 3004513970
- 3010131978
- 3003553186
- 9611813
- 1423662
- 8041151
- 3010009693
- 3015526995
- 3010864832
- 3003537565
- 3005663073
- 3019455
- 3014252644
- 1836116
- 3016096142
- 3009882675
- 3005990145
- 3009051888
- 3008485841
- 9615659
- 2132732
- 3000221762
- 1820334
- 3009381600
- 3006169981
- 3000286616
- 3007695959
- 3008593890
- 3008410596
- 2083544
- 3010676465
- 3012329552
- 3029756087
- 2244478
- 9611102
- 3032747418
- 3016904853
- 8043769
- 1223656
- 1000517406
- 3010437008
- 3004125670
- 2436906
- 3016080683
- 3020468145
- 8010944
- 3005067367
- 9613926
- 3007193505
- 3007728266
- 1000121056
- 2529846
- 1000393132
- 3001297506
- 3023657851
- 3007675948
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code MDM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K073664 | FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCER | Injectimed, Inc. | 2008-08-08 |
| K050575 | FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEM | Futumeds Sdn Bhd | 2005-08-15 |
| K050957 | EUTROCHAR | Special Devices, Inc. | 2005-05-18 |
| K023173 | ANDREWS INTRODUCER, MODEL ASI01 | Andrews Surgical Innovations, Ltd. | 2002-12-18 |
| K022059 | MICROVASIVE PULMONARY GUIDEWIRE | Boston Scientific Corp | 2002-11-13 |
| K013040 | LIGHT SABER INTRODUCER NEEDLE | Minrad, Inc. | 2001-12-07 |
| K010184 | CHESS HAND SURGERY SYSTEM | Canica Design, Inc. | 2001-06-22 |
| K990062 | SAPHLIFT | Genzyme Surgical Product (Genzyme Biosurgery) | 1999-03-30 |
| K981579 | ENDOPOUCH PRO SPECIMEN RETRIEVAL BAG | ETHICON, Inc. | 1998-07-09 |
| K943968 | TUNNELER | Denver Biomedicals, Inc. | 1995-03-01 |
| K945430 | DERMAVBLADE(TM) | Hasting'S Biomedical Corp. | 1994-11-28 |
| K941193 | EAST WEST INSTRUMENTS | East West Instruments, Inc. | 1994-11-09 |
| K941907 | APEX DISPOSABLE INSTRUMENTS | Apex Ent., Inc. | 1994-08-26 |
| K942818 | DEEP SUTURE | Automated Medical Products Corp. | 1994-08-25 |
| K942896 | CLAMPS AND CLIPS | Surgin Surgical Instrumentation, Inc. | 1994-07-19 |
Legacy Summary#
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FDA Review#
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