HEXCELITE
FDA 510(k) clearance K840416 · decided 1984-03-23
Clearance details
- K-number
- K840416
- Device name
- HEXCELITE
- Applicant
- Hexcel Medical
- Decision
- Substantially Equivalent
- Date received
- 1984-01-31
- Decision date
- 1984-03-23
- Days to decision
- 52 days
- Clearance type
- Traditional
- Product code
- ITG
- Device class
- 1
- Regulation number
- 890.3025
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CONFORMA(TM) PLASTER BANDAGES (K873111) | The Kendal Co. | 1987-10-09 |
| DEKNA BAND KIT (K862115) | Deknatel, Inc. | 1986-08-19 |
| T.P.G. CAST TAPE (K842573) | The Poly Group, Inc. | 1984-08-10 |
| NON WETTING UNDERCAST PADDING (K833732) | American Medical Disposable, Inc. | 1983-12-12 |
| SOFFBAN ORTHOPEDIC PADDING (K832992) | Smith & Nephew, Inc. | 1983-11-14 |
| ORTHOPEDIC CASTING TAPE MAXCAST (K832237) | Cutter Laboratories, Inc. | 1983-08-16 |
| SUPPORT PRODUCTS EXAMPLE PROSET CAST (K830650) | Isopedix Corp. | 1983-07-07 |
| YESONA PLASTER OF PARIS BANDAGE (K831492) | Watson Phillips Y Cia. Sucs., S.A. DE C.V. | 1983-06-30 |
| URETHANE ORTHOPAEDIC CASTING TAPE (K820890) | Hexcel Medical | 1982-06-23 |
| WEBRIL CAST PADDING (K820140) | Stan-Pak Ent. | 1982-02-12 |
| SPECIALIST CAST PADDING (K820155) | Stan-Pak Ent. | 1982-02-12 |
| ULTRACAST WATERLESS SYNTHETIC RESIN CAST (K813052) | Zimmer, Inc. | 1982-02-04 |
Recalls involving this device
No recalls on record reference this clearance.