510(k) K772416
- Device
- Pre-formed Splint Blanks
- Applicant
- FRED SAMMONS, INC.
- 510(k) number
- K772416
- Product code
- ILH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-01-05
- Date received
- 1977-12-27
- Regulation
- 890.3475
- Classification name
- Splint, Hand, And Components
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3043326342
- 1000357070
- 3031170295
- 3009561590
- 3017619379
- 1058152
- 3007048017
- 1528759
- 3008494300
- 3007853907
- 3013557562
- 3005273623
- 3008381107
- 3011714258
- 3004713344
- 3008412545
- 3005327291
- 1054236
- 3009754419
- 8010099
- 9710103
- 3013527364
- 1824252
- 3013226
- 3006227741
- 3005157379
- 3008044603
- 3003898328
- 3009273990
- 3030175335
- 3014452647
- 1043534
- 3006554788
- 3008427684
- 3012480144
- 3004067876
- 3011767724
- 3031304621
- 3033519
- 3008770252
- 2249769
- 3011240418
- 3010951384
- 3014672091
- 3016515429
- 3010123014
- 3014599232
- 3016112541
- 9680215
- 3011555947
- 3007076137
- 3020976343
- 3016964847
- 3030539818
- 3015526862
- 3014658541
- 3013374101
- 3027500264
- 3006266055
- 3030501508
- 3004161950
- 3009765870
- 3010409218
- 3006085220
- 9616086
- 3007222848
- 3004526603
- 3014847663
- 3018503755
- 3017264244
- 3029702497
- 2530195
- 3016450032
- 1720839
- 3009131011
- 3004129296
- 3011547262
- 3009746042
- 3023339256
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code ILH#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K832144 | SPLINT WOOD | Vermont Wood Industries, Inc. | 1983-08-01 |
| K831548 | SPLINTS | Fred Sammons, Inc. | 1983-06-27 |
| K823644 | FINGER FLEXION SPLINT | Fred Sammons, Inc. | 1983-01-21 |
| K823647 | FINGER EXTENSION SPLINT | Fred Sammons, Inc. | 1983-01-21 |
| K823666 | UNIVERSAL WRIST SPLINT & FOREARM SPLINT | Warm & Form, Orthopedic Materials | 1982-12-30 |
| K823601 | WRIST SUPPORT | Fred Sammons, Inc. | 1982-12-22 |
| K823393 | STAX FINGER SPLINTS | Orthopedic Systems, Inc. | 1982-12-03 |
| K823165 | WRIST SPLING & FOREARM SPLINT | Warm & Form, Orthopedic Materials | 1982-11-16 |
| K822651 | TOTAL FINGER FLEXION SPLINT | Alimed, Inc. | 1982-09-17 |
| K821635 | SOFT ULNAR DEVIATION SPLINTS | Fred Sammons, Inc. | 1982-06-11 |
| K821637 | WIRE-FOAM MP FLEXION SPRING | Fred Sammons, Inc. | 1982-06-11 |
| K820826 | STAX FINGER SPLINT | Conco Medical Co. | 1982-04-08 |
| K820380 | CURVED FINGER SPLINT | Conco Medical Co. | 1982-03-01 |
| K820381 | FINGER PROTECTOR | Conco Medical Co. | 1982-03-01 |
| K820382 | FROG SPLINT | Conco Medical Co. | 1982-03-01 |