510(k) K861528
- Device
- Tecnol Personal Shoe Cover
- Applicant
- TECHNOL, INC.
- 510(k) number
- K861528
- Product code
- FXP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-05-12
- Date received
- 1986-04-24
- Regulation
- 878.4040
- Classification name
- Cover, Shoe, Operating-Room
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAVID ARCHER
- Address
- 7450 Whitehall Fort Worth TX US 76118 76118
FDA Registration Numbers#
- 3010131137
- 3010656982
- 3012421607
- 9616088
- 3017692139
- 1061124
- 3006942361
- 3015526463
- 3010374920
- 3017408377
- 3005558160
- 3017212217
- 3004980986
- 3017158347
- 3014325808
- 3008048818
- 3031184338
- 3037040712
- 3045058049
- 8043817
- 1818910
- 3033588963
- 3010141571
- 3010595915
- 3042896810
- 3021247124
- 3009736246
- 3015219076
- 3016649599
- 3044150131
- 3011547453
- 3006891803
- 3007165189
- 9611959
- 3018020588
- 3023435669
- 3008466086
- 3008381089
- 3001650535
- 3010154727
- 3016712306
- 3021486363
- 3023339277
- 3010621964
- 3005841027
- 3015058854
- 3017937325
- 3003887292
- 3004105221
- 3004998166
- 2648727
- 3006582165
- 3016705853
- 3031582434
- 3013123550
- 3038718579
- 3011308135
- 3011529314
- 3008808560
- 3006400329
- 3003890648
- 3014314985
- 1422598
- 3016970619
- 3010198795
- 3034669683
- 3013298431
- 9614306
- 3005599545
- 3013260641
- 3009540572
- 2027062
- 3009513193
- 3013269506
- 3016758972
- 3005090771
- 3013502418
- 3016955900
- 3017461111
- 3015140351
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FXP#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K971076 | PRIMED SHOE COVERS, PRIMED HEAD COVERS | Primeline Medical Products, Inc. | 1998-01-13 |
| K971191 | FAR-EAST SHOE COVERS | Far East Science & Technology Development Co., Ltd. | 1997-07-10 |
| K970815 | CONVERTORS IMPERVIOUS SHOE COVERS | Allegiance Healthcare Corp. | 1997-03-27 |
| K961342 | SHOE COVER, NON-STERILE | Copioumed Intl., Inc. | 1996-12-30 |
| K955835 | FLUID BARRIER BOOT KNEE & ANKLE-HIGH | Instrument Makar, Inc. | 1996-11-19 |
| K952937 | NIOMED NON-SKID SHOE COVERS | Amerasia Corp. | 1995-10-23 |
| K952897 | NIOMED SHOE COVERS | Amerasia Corp. | 1995-10-23 |
| K943034 | OREX SHOE COVERS | Thantex Specialties, Inc. | 1995-01-02 |
| K932738 | KAPPLER PRO/VENT BOOT | Kappler, Inc. | 1994-03-29 |
| K925815 | REUSABLE LIQUIDPROOF BOOTIE | Amsco Sterile Recoveries, Inc. | 1993-07-09 |
| K914702 | STERILE VIEW(TM) KNEE-HIGH BOOTS/DEPUY SHOE BOOTS | Depuy, Inc. | 1993-01-29 |
| K913628 | DISPOSABLE SHOE COVER | Gem Nonwovews, Inc. | 1991-10-04 |
| K894383 | DISPOSABLE SHOE COVER | American Threshold Industries, Inc. | 1989-09-12 |
| K893702 | TECNOL GAITERS PRODUCT NUMBER 47725-010 | Tecnol New Jersey Wound Care, Inc. | 1989-06-23 |
| K883657 | SKID RESISTANT, LONG LASTING SHOE COVERS | James River Corp. | 1988-09-15 |