510(k) K791094
- Device
- 3m Orthopedic Casting Tape
- Applicant
- 3M COMPANY
- 510(k) number
- K791094
- Product code
- ITG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1979-07-24
- Date received
- 1979-06-12
- Regulation
- 890.3025
- Classification name
- Bandage, Cast
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 8124 Pacific Ave. White City OR US 97503 97503
FDA Registration Numbers#
- 3004179819
- 3015379055
- 1417592
- 3004116526
- 3024088964
- 3014425119
- 3014409525
- 1526711
- 3030626857
- 3005688007
- 3032911850
- 3016758972
- 3038283966
- 3012660022
- 3004488394
- 1250045
- 3004111573
- 3009931872
- 3026263452
- 3038131022
- 3004122598
- 3026131691
- 8021899
- 3007141284
- 2128677
- 3005621808
- 3008584163
- 1220799
- 8020160
- 3005190268
- 3009526454
- 3005538501
- 3011647251
- 9680455
- 1038963
- 1836161
- 3004605321
- 2028046
- 9614756
- 3006897996
- 3009605026
- 3006973666
- 3003781172
- 3011191255
- 1043644
- 3007084590
- 3038191347
- 3005748172
- 3025306483
- 1824619
- 3010160370
- 3030446844
- 9680357
- 3025430561
- 9680091
- 3014108257
- 3007127018
- 3031184338
- 3044466317
- 8030607
- 3008808049
- 8010200
- 3031582449
- 3014672091
- 3031841433
- 3003887292
- 3004967902
- 1424263
- 3007076137
- 3014663650
- 3034605486
- 3004519921
- 3016603542
- 1054236
- 3010804499
- 3042639641
- 3010967704
- 9616088
- 3032763783
- 3017896419
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code ITG#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K873111 | CONFORMA(TM) PLASTER BANDAGES | The Kendal Co. | 1987-10-09 |
| K862115 | DEKNA BAND KIT | Deknatel, Inc. | 1986-08-19 |
| K842573 | T.P.G. CAST TAPE | The Poly Group, Inc. | 1984-08-10 |
| K840416 | HEXCELITE | Hexcel Medical | 1984-03-23 |
| K833732 | NON WETTING UNDERCAST PADDING | American Medical Disposable, Inc. | 1983-12-12 |
| K832992 | SOFFBAN ORTHOPEDIC PADDING | Smith & Nephew, Inc. | 1983-11-14 |
| K832237 | ORTHOPEDIC CASTING TAPE MAXCAST | Cutter Laboratories, Inc. | 1983-08-16 |
| K830650 | SUPPORT PRODUCTS EXAMPLE PROSET CAST | Isopedix Corp. | 1983-07-07 |
| K831492 | YESONA PLASTER OF PARIS BANDAGE | Watson Phillips Y Cia. Sucs., S.A. DE C.V. | 1983-06-30 |
| K820890 | URETHANE ORTHOPAEDIC CASTING TAPE | Hexcel Medical | 1982-06-23 |
| K820140 | WEBRIL CAST PADDING | Stan-Pak Ent. | 1982-02-12 |
| K820155 | SPECIALIST CAST PADDING | Stan-Pak Ent. | 1982-02-12 |
| K813052 | ULTRACAST WATERLESS SYNTHETIC RESIN CAST | Zimmer, Inc. | 1982-02-04 |
| K813219 | CARAFLEX ELASTIC POLYMER PLASTER BANDA | Carapace, Inc. | 1981-12-17 |
| K811754 | CRYSTONA | Smith & Nephew, Inc. | 1981-07-20 |