510(k) K990062
- Device
- SAPHLIFT
- Applicant
- GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)
- 510(k) number
- K990062
- Product code
- MDM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-03-30
- Date received
- 1999-01-08
- 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
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Ruth Forstadt
- Address
- 49 Plain St. North Attleboro MA US 02760 02760
FDA Registration Numbers#
- 3043620689
- 9617601
- 2184171
- 3034688516
- 3027339877
- 3010047454
- 1226191
- 1833986
- 3007478714
- 3011300255
- 1721504
- 3012995405
- 3012587552
- 3009468807
- 3008843439
- 3010864832
- 9615659
- 3003973936
- 3001297506
- 1222780
- 3008352964
- 3008370577
- 3010611926
- 3010889707
- 3014479313
- 3013510285
- 2027148
- 2183785
- 3043648115
- 8010916
- 2433012
- 3017450368
- 3005528784
- 3003477135
- 3020954746
- 3004705187
- 3009763019
- 3001650535
- 3008338766
- 3011050570
- 9614062
- 9615004
- 3015378469
- 3007329020
- 3015526995
- 3006395932
- 3004361445
- 3007695959
- 3008496217
- 3008887731
- 3030149892
- 3014314985
- 9612354
- 8010370
- 1000606483
- 3015895045
- 3039169546
- 3011307621
- 3013820441
- 1932402
- 3008593890
- 1649660
- 3003537565
- 1211566
- 9613793
- 3017565094
- 3035708926
- 3013767421
- 2246990
- 3003988575
- 3042235752
- 3018094310
- 3010386387
- 3024433356
- 1043214
- 3009051888
- 1061927
- 3038776593
- 9611262
Source Documents#
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 |
| 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 |
| K940684 | SURGICAL INSTRUMENT, DISPOSABLE | Her-Mar, Inc. | 1994-03-14 |
Legacy Summary#
summary
FDA Review#
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