510(k) K863179
- Device
- KIMLON DISPOSABLE BLANKET
- Applicant
- KIMBERLY-CLARK CORP.
- 510(k) number
- K863179
- Product code
- KME
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-08-27
- Date received
- 1986-08-18
- 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
- CYNTHIA SMITH
- Address
- 1400 Holcomb Bridge Rd. Roswell GA US 30076 30076
FDA Registration Numbers#
- 3011140825
- 3016680688
- 3006755899
- 3038772401
- 3011434305
- 3006517436
- 3014610488
- 2085602
- 9611451
- 3030498909
- 3030536686
- 3010374920
- 3009750121
- 8030607
- 3038285060
- 1319302
- 3018296902
- 3015378469
- 3014345255
- 3012811961
- 3008339799
- 1041732
- 1525567
- 3014108257
- 3015528095
- 1123010
- 3010402957
- 3005460813
- 3008489813
- 3008392711
- 3007307589
- 3045058049
- 3010383831
- 3018179422
- 3017398283
- 3011526299
- 3017492908
- 3009745997
- 3020460367
- 3023339277
- 3005165456
- 3017558212
- 3013414322
- 3026222938
- 3005609751
- 3019848304
- 3003495693
- 3043648115
- 3008959420
- 3014268334
- 1034876
- 3012606450
- 3014146451
- 3030678923
- 3016860525
- 3017910185
- 3013427445
- 3017494285
- 3011280379
- 3012242151
- 3010363542
- 3038283966
- 3014330970
- 3016955900
- 3023141635
- 3011270181
- 3013226
- 3009492409
- 9616096
- 3017417635
- 1055892
- 3015309643
- 3013735158
- 3014527916
- 3016507522
- 3031595580
- 3007084580
- 3014409525
- 1043644
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 |
| K911948 | MEDI GUARD PILLOWCASE | Sancella, Inc. | 1991-05-28 |
| K911952 | MEDI GUARD UNDERPAD | Sancella, Inc. | 1991-05-28 |
| K911953 | MEDI GUARD SHEETS/UNDERLAYS | Sancella, Inc. | 1991-05-28 |
| K911950 | MEDI GUARD DRAPES | Sancella, Inc. | 1991-05-21 |
| K905003 | BIO-GUARD SHAVE PREP TRAY | Network Medical Systems, Inc. | 1990-12-28 |
| 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 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases