510(k) K801824
- Device
- Band-aid Brand Flexible Fabric Bandage
- Applicant
- JOHNSON & JOHNSON PROFESSIONALS, INC.
- 510(k) number
- K801824
- Product code
- KGY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-08-20
- Date received
- 1980-07-31
- Regulation
- 878.4100
- Classification name
- Bag, Intestine
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 325 Paramount Dr. Raynham MA US 02767 02767
FDA Registration Numbers#
- 3010155661
- 3017636737
- 2027062
- 1423537
- 3009540516
- 3006425876
- 1060680
- 3014656749
- 1043214
- 3008432385
- 1216677
- 9680284
- 3008044603
- 2939142
- 1921846
- 3006897996
- 3031841433
- 3010693885
- 3031757047
- 1055236
- 3021970868
- 8043817
- 2085947
- 1825146
- 3015219237
- 3008132398
- 3006210673
- 3041276890
- 3009750712
- 3010372554
- 3042272797
- 1820334
- 3022320321
- 1054241
- 1061124
- 3008571754
- 3008439467
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KGY#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K933085 | GOODMAN BANDAGE | Megadyne Medical Products, Inc. | 1993-12-23 |
| K913678 | TROCAR CATHETER | Medovations, Inc. | 1991-12-16 |
| K910914 | SURGICAL TISSUE POUCH | Cook Urological, Inc. | 1991-03-28 |
| K832318 | ISOLATION BAG 3M | 3M Company | 1983-10-31 |
| K801823 | BAND-AID BRAND TRICOT MESH BANDAGES | Johnson & Johnson Professionals, Inc. | 1980-08-20 |