510(k) K771452
- Device
- CONFORM STRETCH BANDAGE (5SIZES)
- Applicant
- Kendall Research Center
- 510(k) number
- K771452
- Product code
- ITG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-09-12
- Date received
- 1977-08-03
- Regulation
- 890.3025
- Classification name
- Bandage, Cast
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 2435946
- 3015058854
- 3010160370
- 9616088
- 3031841433
- 3032911850
- 3014108257
- 8020160
- 3005538501
- 3017417635
- 3043326342
- 3010804499
- 8021899
- 3014150341
- 3031167704
- 3031184338
- 3013410562
- 3014672091
- 2011171
- 1063411
- 3010967704
- 3012711490
- 3014663650
- 3035642068
- 2182345
- 3013557562
- 2320762
- 1054241
- 9680222
- 3009526454
- 3004777506
- 3030446844
- 3012341425
- 3005841027
- 3008044484
- 3006264736
- 3004122598
- 1423537
- 3032763783
- 3025306483
- 3005621808
- 1043644
- 3008016588
- 3019756084
- 3045742729
- 3025430561
- 9710641
- 9616494
- 3011287176
- 3007865243
- 3008584163
- 9611024
- 8030654
- 3005103920
- 3010621964
- 9680091
- 3027498673
- 3003484636
- 8030607
- 3017896419
- 3011647251
- 3031582449
- 3038283966
- 2128677
- 1055236
- 2242467
- 3001124136
- 1417592
- 3013496867
- 3006113262
- 1060680
- 3004111573
- 3009067117
- 1043214
- 3010195489
- 3004869142
- 3006973666
- 3008808082
- 3004617746
- 3045857302
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 |