510(k) K955835
- Device
- FLUID BARRIER BOOT KNEE & ANKLE-HIGH
- Applicant
- INSTRUMENT MAKAR, INC.
- 510(k) number
- K955835
- Product code
- FXP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-11-19
- Date received
- 1995-12-26
- Regulation
- 878.4040
- Classification name
- Cover, Shoe, Operating-room
- Medical specialty
- General & Plastic Surgery
- Review panel
- General Hospital
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- BRENDA J SPARKS
- Address
- 2950 E. Mt. Hope Rd. Okemos MI US 48864 48864
FDA Registration Numbers#
- 9681385
- 3006799943
- 3010653892
- 1423537
- 3034602341
- 3016668451
- 3016686946
- 3006538822
- 1219103
- 9681151
- 3034669683
- 3016450032
- 3010162721
- 3012267116
- 3005621808
- 3012268821
- 1932271
- 3007165189
- 1419562
- 3007289408
- 1450420
- 3014257280
- 3019458442
- 3013006775
- 3034629649
- 3016955900
- 3030678923
- 3006897996
- 3010508273
- 3004998166
- 3003849847
- 3011424870
- 3017180923
- 2523138
- 3003887292
- 3011434305
- 3010147274
- 3011707926
- 3006113262
- 3008770063
- 3017417635
- 9680357
- 3015526463
- 3008311433
- 3031582434
- 3009489102
- 3003495693
- 9613910
- 9617805
- 9616088
- 3005599545
- 3036893546
- 2433012
- 3043648115
- 3007339875
- 3017911878
- 3011529314
- 3016758972
- 3014666579
- 3033848619
- 8030654
- 3001650535
- 1054241
- 3008868758
- 3004930567
- 3009233038
- 3016452400
- 3016195105
- 3023435669
- 3005558160
- 3004905643
- 3013502418
- 3014314985
- 9614306
- 3016994953
- 3017846745
- 3016705853
- 3016763307
- 3017597597
Source Documents#
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 |
| 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 |
| K882280 | COVER, SHOE OPERATING ROOM | A Plus International, Inc. | 1988-06-23 |
Legacy Summary#
summary
FDA Review#
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