WINTER HEAD DRESSING
FDA 510(k) clearance K801458 · decided 1980-07-28
Clearance details
- K-number
- K801458
- Device name
- WINTER HEAD DRESSING
- Applicant
- Steridyne Corp.
- Decision
- Substantially Equivalent
- Date received
- 1980-06-24
- Decision date
- 1980-07-28
- Days to decision
- 34 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.