BANDAGE, ELASTIC
FDA 510(k) clearance K780231 · decided 1978-02-21
Clearance details
- K-number
- K780231
- Device name
- BANDAGE, ELASTIC
- Applicant
- Biomet, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-02-09
- Decision date
- 1978-02-21
- Days to decision
- 12 days
- Clearance type
- Traditional
- Product code
- FQM
- Device class
- 1
- Regulation number
- 880.5075
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- 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 |
|---|---|---|
| PETIT SILMA ELASTIC BANDAGE WITH GERMANIUM/TITANIUM OXIDE (K040936) | Leda Co., Ltd. | 2004-05-03 |
| BACK IN ACTION COMPRESSION & SUPPORT WITH MAGNETS FOR THE LOWER BACK, KNEE AND ANKLE (K040054) | Theodore Barash | 2004-04-27 |
| COMFORTCARE COMPRESSION SUPPORT WITIH MAGNETS AND AEGIS MICROBE SHIELD COMFORTCARE MAGNETIC INSOLES AND AEGIS MICROBE (K013244) | Med Gen, Inc. | 2001-12-07 |
| SKIN SAVER SYSTEMS (K952738) | Skin Saver Systems, Inc. | 1995-09-29 |
| ASPEN ESMARK BANDAGE (K872868) | Aspen Laboratories, Inc. | 1987-07-31 |
| TUBE-BANDAGE FOR HUMAN DIGITS 200 (K840107) | Zens Health Care Products | 1984-04-25 |
| MEDICALEX (K831728) | Medicalex | 1984-01-09 |
| ORTHO WRAP (K830622) | Fast Wrap Co., Inc. | 1983-06-20 |
| COMPRESSOGRIP TUBULAR ELASTIC BANDAGE (K831551) | Fred Sammons, Inc. | 1983-06-07 |
| BIAS STOCKINETTE (K820141) | Stan-Pak Ent. | 1982-02-05 |
| TUBULAR STOCKINETTE (K820142) | Stan-Pak Ent. | 1982-02-05 |
| ELASTIC BANDAGE (K820094) | Stan-Pak Ent. | 1982-01-29 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| C2A-TAPER ACETABULAR HIP SYSTEM (P050009/S009) | Biomet, Inc. | 2011-02-11 |
| C2A-TAPER ACETABULAR SYSTEM (P050009/S004) | Biomet, Inc. | 2009-04-17 |
| C2A TAPER ACETABULAR SYSTEM (P050009/S007) | Biomet, Inc. | 2009-03-13 |
| C2-A TAPER ACETABULAR SYSTEM (P050009/S005) | Biomet, Inc. | 2007-11-30 |
| C2A-TAPER ACETABULAR SYSTEM (P050009/S002) | Biomet, Inc. | 2006-06-16 |
| C2A-TAPER ACETABULAR SYSTEM (P050009/S001) | Biomet, Inc. | 2006-02-01 |
| C2 A-TAPER ACETABULAR SYSTEM (P050009) | Biomet, Inc. | 2005-12-16 |