510(k) K905003
- Device
- Bio-guard Shave Prep Tray
- Applicant
- NETWORK MEDICAL SYSTEMS, INC.
- 510(k) number
- K905003
- Product code
- KME
- Decision
- Unknown (SESK)
- Decision date
- 1990-12-28
- Date received
- 1990-11-07
- Regulation
- 880.6060
- Classification name
- Bedding, Disposable, Medical
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- SAM HAMOUIE
- Address
- 4901 Milwee, #202 Houston TX US 77092 77092
FDA Registration Numbers#
- 3037012186
- 3038283966
- 3004468406
- 1319302
- 3007865243
- 1423537
- 3015288041
- 3031231834
- 3003674698
- 2032476
- 3006538822
- 3014409525
- 9615551
- 3043153496
- 3034669683
- 3014739961
- 3013440654
- 3004713352
- 3011642792
- 3019545200
- 3026858378
- 3038632739
- 3031841433
- 3016955900
- 3018117722
- 3010147274
- 3024761165
- 3008770063
- 3016879560
- 3017417635
- 3008311433
- 1000136371
- 1525567
- 3015287620
- 3016995280
- 1054241
- 3038274448
- 3004930567
- 1928237
- 3012811961
- 3016452400
- 3012595397
- 3005558160
- 3015528095
- 3003696170
- 3038285060
- 1181047
- 1528440
- 3012137459
- 3019848304
- 9611959
- 3006336810
- 3033858895
- 9680284
- 3013682767
- 3006123105
- 1121142
- 1422598
- 3025413691
- 3031595580
- 3031606500
- 3016674288
- 3007134585
- 3023339277
- 3014601456
- 3006400320
- 3010864832
- 3008851420
- 3044466317
- 3009750121
- 1824206
- 3041276890
- 3015416207
- 3012309743
- 3008489813
- 3017461111
- 3033790380
- 3004911384
- 3014883395
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KME#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K042145 | READY-HEAT BLANKET | Techtrade, LLC | 2004-09-17 |
| K944953 | OREX MEDICAL BEDDING | Thantex Specialties, Inc. | 1994-12-02 |
| K933636 | DISPOSE-A-SHEET | Belmac Healthcare Corp. | 1994-01-26 |
| K932539 | DOCTOR DOWN --RESCUE WRAP | Three Dog Down | 1993-11-02 |
| K922143 | AMERICAN BURN SHEET | American Silk Sutures, Inc. | 1992-08-10 |
| K915303 | FOIL BABY BUNTING | Gam Industries, Inc. | 1992-02-20 |
| K912257 | CHEM-SLEEVE B | Haz-Med, Inc. | 1991-12-31 |
| K911953 | MEDI GUARD SHEETS/UNDERLAYS | Sancella, Inc. | 1991-05-28 |
| K911952 | MEDI GUARD UNDERPAD | Sancella, Inc. | 1991-05-28 |
| K911948 | MEDI GUARD PILLOWCASE | Sancella, Inc. | 1991-05-28 |
| K911950 | MEDI GUARD DRAPES | Sancella, Inc. | 1991-05-21 |
| K904274 | RECEIVING BLANKET | Anago, Inc. | 1990-10-26 |
| K901509 | TRAUMA SLEEVE | Haz-Med, Inc. | 1990-09-12 |
| K901629 | CHEM-SLEEVE | Haz-Med, Inc. | 1990-04-27 |
| K900643 | FLUID SOAKERSHIELD | Infection Control Products, Inc. | 1990-04-25 |