510(k) K843400
- Device
- Hydro-splint A Sponge-compress Dress
- Applicant
- COMPRESSION SPLINT PRODUCTS, INC.
- 510(k) number
- K843400
- Product code
- FYH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-10-24
- Date received
- 1984-08-30
- Regulation
- 878.3910
- Classification name
- Splint, Extremity, Noninflatable, External, Sterile
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- TONY I INVORVAIA
- Address
- P.O. Box 7407 Pittsburgh P US 15213 15213
FDA Registration Numbers#
- 8020160
- 3017633586
- 3022381831
- 3042251637
- 1025972
- 9680794
- 3006621348
- 9612388
- 1931876
- 9680271
- 1417592
- 1928237
- 9616933
- 3012307300
- 3007109661
- 3014144875
- 1926174
- 1000560772
- 8022890
- 3032597249
- 3031288561
- 3013152643
- 3006805143
- 3023917
- 3004617746
- 1214422
- 3008395114
- 3035374295
- 3018071447
- 3003855936
- 1219313
- 2027062
- 3038283966
- 2027804
- 1640867
- 3008114969
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FYH#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K925145 | TRACE MODEL #'S 840, 841, 842, 845 | Trace Medical Equipment, Inc. | 1993-05-19 |
| K924984 | SPECIALIST(R) WALKER | Johnson & Johnson Orthopaedics, Inc. | 1993-02-01 |
| K895092 | KUT-SHIELD | Kut-Guard, Inc. | 1989-09-26 |
| K852558 | SPLINTS(ALL TYPE) | The Huxley Instrument Corp. | 1985-07-02 |
| K821693 | J & J DIP WATER ADDITIVE | Johnson & Johnson Professionals, Inc. | 1982-07-02 |
| K802522 | DELTA-LITE CASTING TAPE & SPLINTS | Johnson & Johnson Professionals, Inc. | 1981-01-08 |
| K801436 | ORTHOPEDIC LOWER EXTREMITY SUSPENSION | Orthopedic Systems, Inc. | 1980-06-26 |