510(k) K920297
- Device
- DISPOSABLE SCISSORS
- Applicant
- FALCON INSTRUMENTS, INC.
- 510(k) number
- K920297
- Product code
- MDM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-09-11
- Date received
- 1992-01-22
- 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
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- DUNNING
- Address
- 8309 Bryant Dr. Bethesda MD US 20817 20817
FDA Registration Numbers#
- 3003244954
- 3028006458
- 3006591312
- 3004950803
- 1062741
- 1720747
- 1063481
- 8010273
- 3004450489
- 1057358
- 1000606483
- 1416666
- 3006801265
- 3010047402
- 3009493875
- 3004892425
- 8043496
- 3005748481
- 3016248634
- 9617592
- 2031528
- 3043648115
- 9611590
- 3006425876
- 3008864603
- 3013510285
- 3010583458
- 3017717188
- 3003139373
- 3006846753
- 8043404
- 3004837686
- 3031231776
- 3004111573
- 8043746
- 3033589330
- 3010437008
- 9681479
- 3008911114
- 3010071016
- 3010400367
- 2424531
- 2431453
- 8023033
- 3008936260
- 3021336182
- 2434839
- 3011230048
- 2530138
- 2518634
- 3032391
- 3042278955
- 3007193505
- 3011050570
- 3005990145
- 3036756245
- 3034676720
- 3015532217
- 8040233
- 3003882387
- 8010422
- 9611617
- 3010405299
- 3009822485
- 3000682787
- 8040373
- 3008254127
- 2242450
- 3009968482
- 3010039400
- 1836116
- 1828288
- 9614075
- 3011659880
- 3016989300
- 1038671
- 1219655
- 3003537565
- 3007378235
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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