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#
- 3014279513
- 3018940271
- 3006765019
- 3021519357
- 3008720584
- 3015806723
- 3045058049
- 3042235752
- 1526534
- 9680721
- 3003882387
- 3029507159
- 8043404
- 9612354
- 8044098
- 3042624965
- 3010595915
- 2320767
- 3005809810
- 3010380518
- 3005641619
- 3007024186
- 2183449
- 9613079
- 3014201171
- 1625685
- 9611390
- 9680620
- 3003973936
- 1211998
- 8043769
- 3010202439
- 8043746
- 3036269993
- 3004837686
- 1123137
- 9611612
- 9611112
- 3008114965
- 3042278955
- 9610617
- 2182345
- 3014262693
- 3012366928
- 3016851379
- 3005599545
- 1055890
- 1038671
- 3009513193
- 1054811
- 3000221762
- 1932402
- 2431453
- 3003435550
- 3011767135
- 3009704301
- 3017196117
- 3004009671
- 2435946
- 3009468807
- 1226146
- 1060680
- 3017859830
- 3030926959
- 3008254127
- 1721504
- 9611610
- 3010162782
- 3011301313
- 3009742443
- 3012619291
- 3011300255
- 9681860
- 1018233
- 3013530901
- 9710058
- 3010303097
- 2183930
- 3003019064
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 |