510(k) K043526
- Device
- SILVERSEAL TUBULAR WOUND DRESSING WITH X-STATIC
- Applicant
- Noble Fiber Technologies, Inc.
- 510(k) number
- K043526
- Product code
- LGF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-03-10
- Date received
- 2004-12-21
- Regulation
- 888.5940
- Classification name
- Component, Cast
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- PATRICIA DAVIDSON
- Address
- 421 S. State St. Clarks Summit PA US 18411 18411
FDA Registration Numbers#
- 8020160
- 2245519
- 9613183
- 3017633586
- 3017171460
- 3038718579
- 3034669683
- 3014150341
- 3014108257
- 3006943846
- 3017264244
- 3003965134
- 1424774
- 9612388
- 3005621808
- 3031167704
- 3004753358
- 1417592
- 1062671
- 3010309201
- 3008879776
- 1932015
- 1038963
- 9681385
- 3009290468
- 3010131137
- 3005273623
- 3007084590
- 9710020
- 3019756084
- 8043750
- 3017262662
- 3008044484
- 3012344767
- 9680215
- 3005869201
- 3015140351
- 9680222
- 3013410562
- 3010198795
- 3015194285
- 3006897996
- 3007865243
- 3009119999
- 9616086
- 3010595009
- 3014368824
- 3008852306
Source Documents#
Other 510(k) Records For Product Code LGF#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K973420 | CLINITEX CAST PADDING | Clinitex Medical Corp. | 1997-12-09 |
| K973417 | CLINITEX STOCKINETTE | Clinitex Medical Corp. | 1997-12-09 |
| K955320 | PROTEC COTTON PADDING BANDAGE | Derivadas Degasa S.A. DE C.V. | 1996-01-26 |
| K932507 | QUICK-CAST IMMOBILIZER | Landec Corp. | 1994-02-23 |
| K931672 | CARAPACE STERILE CAST PADDING | Carapace, Inc. | 1993-12-15 |
| K910274 | ARTIFLEX(TM) | Beiersdorf, Inc. | 1991-03-05 |
| K903946 | COOL CAST(R) | Hawthorne Products, Inc. | 1990-12-31 |
| K896634 | CARAGLAS XTRA SYNTHETIC CASTING TAPE | Buckman Co., Inc. | 1990-06-14 |
| K883294 | SYNTHETIC CAST TAPE | Carapace, Inc. | 1988-08-30 |
| K874880 | COLORED CASTING TAPE CARAGLAS(TM GREEN | Synthetic Mfg., Inc. | 1987-12-30 |
| K873722 | PEDESTAL WALKING HEEL PRODUCT NO. 4183-133 | Martin Medical | 1987-10-02 |
| K873718 | CHILD WALKING HEEL PRODUCT NO. 4183-132 | Martin Medical | 1987-10-02 |
| K873717 | CUSHION TREAD WALKING HEEL PRODUCT NO. 4183-135 | Martin Medical | 1987-10-02 |
| K870404 | COLORED CASTING TAPE (RED AND BLUE) | Buckman Co., Inc. | 1987-02-13 |
| K864092 | OEC DESIGN ORTHOPEDIC CAST HEEL | Military Engineering, Inc. | 1986-12-16 |