510(k) K761114
- Device
- Foam Slippers
- Applicant
- FRED SAMMONS, INC.
- 510(k) number
- K761114
- Product code
- IPM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1976-12-02
- Date received
- 1976-11-19
- Regulation
- 890.3025
- Classification name
- Cover, Limb
- 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#
- 1063411
- 3018070833
- 3004122598
- 2133465
- 3005748450
- 3017633586
- 1022826
- 3003764610
- 3009417901
- 1314417
- 1058311
- 1000357070
- 3003464828
- 3010694026
- 1911617
- 3045816902
- 9616088
- 2242474
- 1649518
- 1043591
- 3030413824
- 9612243
- 3007420886
- 3004824601
- 2027062
- 9681133
- 9616086
- 3010452421
- 3005282622
- 9616494
- 3005621808
- 3010508273
- 3045857302
- 1043214
- 2028253
- 3014368824
- 2950684
- 3007076137
- 3017697481
- 3008016588
- 3007543825
- 1926174
- 3045816907
- 1000119796
- 3004905643
- 3012205931
- 3016172261
- 1423537
- 3014747863
- 3029975230
- 3007914557
- 3004161950
- 1063312
- 3012841710
- 1054241
- 1824252
- 3024891479
- 3004488394
- 3027500264
- 2031918
- 3009285151
- 2031823
- 3006707030
- 3005037196
- 9710020
- 1522166
- 9613558
- 3008259931
- 3005841961
- 3014421917
- 3003890514
- 3007615436
- 1037885
- 3016171961
- 3007510149
- 1836161
- 1000228440
- 3017958535
- 1060680
- 1424263
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IPM#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K872488 | ELASTO-GEL CAST & SPLINT PADS | Southwest Technologies, Inc. | 1987-09-21 |
| K823399 | COVER LIMB | Orthopedic Systems, Inc. | 1982-11-29 |
| K801627 | COVER, LIMB | The Owenby Co. | 1980-07-28 |
| K780905 | LIMB COVER | Hydro-Med Products, Inc. | 1978-08-14 |
| K770223 | HEAVY FOAM HEEL & ELBOW PROTECTORS | Robert R. Moore | 1977-02-23 |