510(k) K992539
- Device
- Percuguard
- Applicant
- DIGIT-PRO
- 510(k) number
- K992539
- Product code
- LZB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-02-18
- Date received
- 1999-07-30
- Regulation
- 880.6250
- Classification name
- Finger Cot
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- KEVIN SORRELS
- Address
- 10555 W. Little York Rd. Houston TX US 77041 77041
FDA Registration Numbers#
- 3007123908
- 3006210673
- 3016707060
- 3016851379
- 3010138147
- 3004365956
- 3007187674
- 1025972
- 1220246
- 3005533873
- 3007838093
- 1210513
- 3026263452
- 3043648115
- 3011137372
- 2435946
- 3015140199
- 3005951403
- 3006943846
- 3034605486
- 3001650535
- 3006537699
- 3004950768
- 3014004349
- 1226146
- 1417592
- 3010187802
- 3017910185
- 3033113207
- 2023344
- 3014683120
- 3012818475
- 3021282544
- 8043323
- 3006227741
- 3007744213
- 1423205
- 3031288561
- 3007109793
- 2029275
- 3023917
- 3012314549
- 3023812384
- 3005273623
- 3030220271
- 3016450032
- 3008352964
- 2246552
- 3011089435
- 3020704423
- 3012711490
- 3010934856
- 3010400367
- 3003807757
- 3011862887
- 3025413691
- 2086043
- 3011715922
- 9617453
- 3009307523
- 3010331645
- 3017417635
- 3024088964
- 3009540516
- 3008384335
- 3008808049
- 3011983031
- 3008808082
- 3021234378
- 3030539818
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LZB#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K052387 | ARTHREX FINGERSHIELD FINGER GUARD, MODEL AR-7199-XX | Arthrex, Inc. | 2005-11-29 |
| K980827 | LATEX FINGER COT, POWDER-FREE, WITH PROTEIN LABELING | Tucker & Associates | 1998-05-04 |
| K912042 | BETHEL PLUS MULTIPLE NAMES | Bethel Latex Products, Inc. | 1991-07-02 |
| K903073 | LATEX FINGER COTS | Dongkuk Trading Co., Ltd. | 1990-09-12 |