510(k) K801627
- Device
- Cover, Limb
- Applicant
- THE OWENBY CO.
- 510(k) number
- K801627
- Product code
- IPM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-07-28
- Date received
- 1980-07-15
- 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#
- 1527846
- 9615149
- 3007392395
- 3021581046
- 1522166
- 1063411
- 3015414875
- 3025355675
- 1000228440
- 3006943846
- 3010595915
- 1060680
- 1061124
- 1221541
- 3024891479
- 3007420886
- 1058152
- 3004161950
- 1000357070
- 3015960622
- 3029975230
- 9710020
- 3015173212
- 1314417
- 3004111573
- 3006707030
- 2133465
- 1054236
- 3011120089
- 3016171961
- 3003890514
- 2320762
- 8031005
- 3008259931
- 1054241
- 3004967086
- 8030901
- 1225916
- 9613910
- 3015146876
- 3017633586
- 3005282622
- 8010822
- 1824252
- 9616872
- 3014658541
- 3027500264
- 1928237
- 1836161
- 3017936957
- 3006227741
- 8022890
- 2024311
- 2545
- 1037885
- 3010452421
- 1424263
- 1043214
- 1834241
- 1030451
- 3003464828
- 3004905643
- 1058311
- 9612243
- 3005276041
- 3007914557
- 3003849847
- 3016172261
- 2027062
- 1063312
- 3007615436
- 3021394836
- 9616086
- 3003764610
- 3014947080
- 3004824601
- 2184046
- 3005012805
- 2950684
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 |
| K780905 | LIMB COVER | Hydro-Med Products, Inc. | 1978-08-14 |
| K770223 | HEAVY FOAM HEEL & ELBOW PROTECTORS | Robert R. Moore | 1977-02-23 |
| K761114 | FOAM SLIPPERS | Fred Sammons, Inc. | 1976-12-02 |