510(k) K040936
- Device
- PETIT SILMA ELASTIC BANDAGE WITH GERMANIUM/TITANIUM OXIDE
- Applicant
- Leda Co., Ltd.
- 510(k) number
- K040936
- Product code
- FQM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-05-03
- Date received
- 2004-04-09
- Regulation
- 880.5075
- Classification name
- Bandage, Elastic
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- DAVID J BLOCH
- Address
- 1301 K St. NW Suite 1100, E. Tower Washington DC US 20005 20005
FDA Registration Numbers#
- 3038283966
- 3003062321
- 3007865243
- 1423537
- 3011987967
- 3017297225
- 3003674698
- 3006538822
- 3014409525
- 3009761558
- 1222313
- 3034669683
- 3022424674
- 3009349165
- 3011642792
- 3007299770
- 1038963
- 3031841433
- 3005423373
- 3030956456
- 2183164
- 3017417635
- 9616765
- 3006993855
- 3009009512
- 3015997711
- 1018120
- 8030128
- 3004651767
- 3015895045
- 3017672584
- 9614874
- 1054241
- 2025881
- 3001448308
- 3038274448
- 1928237
- 3013857401
- 3043051412
- 3010097171
- 3005037196
- 3017633586
- 3004083376
- 3020188747
- 1528440
- 3012137459
- 3021630959
- 8043782
- 9616933
- 9611959
- 3006336810
- 3033858895
- 9680284
- 3021286079
- 1121142
- 3007766601
- 1422598
- 3025413691
- 3012865799
- 9616086
- 3003546412
- 3015043014
- 3023339277
- 3008386507
- 9612051
- 3006400320
- 3009605026
- 3044466317
- 1036836
- 2530138
- 3021228307
- 3011536935
- 3030528528
- 3013960199
- 3033451996
- 3012309743
- 3015414796
- 3004911384
- 1061124
Source Documents#
Other 510(k) Records For Product Code FQM#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K040054 | BACK IN ACTION COMPRESSION & SUPPORT WITH MAGNETS FOR THE LOWER BACK, KNEE AND ANKLE | Theodore Barash | 2004-04-27 |
| K013244 | COMFORTCARE COMPRESSION SUPPORT WITIH MAGNETS AND AEGIS MICROBE SHIELD COMFORTCARE MAGNETIC INSOLES AND AEGIS MICROBE | Med Gen, Inc. | 2001-12-07 |
| K952738 | SKIN SAVER SYSTEMS | Skin Saver Systems, Inc. | 1995-09-29 |
| K872868 | ASPEN ESMARK BANDAGE | Aspen Laboratories, Inc. | 1987-07-31 |
| K840107 | TUBE-BANDAGE FOR HUMAN DIGITS 200 | Zens Health Care Products | 1984-04-25 |
| K831728 | MEDICALEX | Medicalex | 1984-01-09 |
| K830622 | ORTHO WRAP | Fast Wrap Co., Inc. | 1983-06-20 |
| K831551 | COMPRESSOGRIP TUBULAR ELASTIC BANDAGE | Fred Sammons, Inc. | 1983-06-07 |
| K820142 | TUBULAR STOCKINETTE | Stan-Pak Ent. | 1982-02-05 |
| K820141 | BIAS STOCKINETTE | Stan-Pak Ent. | 1982-02-05 |
| K820094 | ELASTIC BANDAGE | Stan-Pak Ent. | 1982-01-29 |
| K811173 | STRUVA & MEDI | Weco | 1981-06-18 |
| K810137 | SOF-BAND HIGH STRETCH BANDAGES | Johnson & Johnson Professionals, Inc. | 1981-02-17 |
| K802992 | ELASTIC GAUZE | Abco Dealers, Inc. | 1980-12-30 |
| K802991 | ROLL STRETCH GAUZE | Abco Dealers, Inc. | 1980-12-30 |