510(k) K050575
- Device
- FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEM
- Applicant
- Futumeds Sdn Bhd
- 510(k) number
- K050575
- Product code
- MDM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-08-15
- Date received
- 2005-03-07
- 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
- N
Applicant Contact#
- Contact
- LEONG PEI PING
- Address
- # 3, Jalan Puchong, Batu 12 1/2 Puchong MY 47100 47100
FDA Registration Numbers#
- 1043646
- 3016851379
- 3010635845
- 3013429557
- 8010374
- 3004112621
- 3010383831
- 8010379
- 3014967149
- 9611502
- 1820334
- 3004464325
- 1000121056
- 3012366928
- 2083544
- 3003403260
- 3010097171
- 3007007790
- 3008812251
- 3005273623
- 3016727307
- 3004358587
- 2518634
- 3012656745
- 3013358456
- 3013156185
- 1932402
- 9614068
- 8010099
- 3010370554
- 3023809973
- 3006082230
- 9680620
- 3010353405
- 2182291
- 3010583458
- 3012470322
- 3005075853
- 3010515776
- 3021226419
- 3011024991
- 3010386387
- 3019543072
- 3021519357
- 3009887475
- 1835998
- 3007663056
- 3017450368
- 3020899789
- 2031910
- 3011301313
- 1423507
- 1423662
- 2133928
- 1036836
- 3009882675
- 3003431869
- 1043534
- 3006128100
- 8043496
- 2028046
- 8010405
- 3010288346
- 3012733432
- 3012507533
- 3005636544
- 3037407500
- 1928237
- 9614093
- 3009189869
- 3007279848
- 3008770252
- 2183650
- 1056350
- 3015183635
- 9611813
- 9615021
- 3005099803
- 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 |
| 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 |
| K940684 | SURGICAL INSTRUMENT, DISPOSABLE | Her-Mar, Inc. | 1994-03-14 |