SHOW'RBAG
FDA 510(k) clearance K822059 · decided 1982-07-22
Clearance details
- K-number
- K822059
- Device name
- SHOW'RBAG
- Applicant
- The Healthcare Group Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-07-13
- Decision date
- 1982-07-22
- Days to decision
- 9 days
- Clearance type
- Traditional
- Product code
- LGF
- Device class
- 1
- Regulation number
- 888.5940
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- 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 |
|---|---|---|
| SILVERSEAL TUBULAR WOUND DRESSING WITH X-STATIC (K043526) | Noble Fiber Technologies, Inc. | 2005-03-10 |
| CLINITEX CAST PADDING (K973420) | Clinitex Medical Corp. | 1997-12-09 |
| CLINITEX STOCKINETTE (K973417) | Clinitex Medical Corp. | 1997-12-09 |
| PROTEC COTTON PADDING BANDAGE (K955320) | Derivadas Degasa S.A. DE C.V. | 1996-01-26 |
| QUICK-CAST IMMOBILIZER (K932507) | Landec Corp. | 1994-02-23 |
| CARAPACE STERILE CAST PADDING (K931672) | Carapace, Inc. | 1993-12-15 |
| ARTIFLEX(TM) (K910274) | Beiersdorf, Inc. | 1991-03-05 |
| COOL CAST(R) (K903946) | Hawthorne Products, Inc. | 1990-12-31 |
| CARAGLAS XTRA SYNTHETIC CASTING TAPE (K896634) | Buckman Co., Inc. | 1990-06-14 |
| SYNTHETIC CAST TAPE (K883294) | Carapace, Inc. | 1988-08-30 |
| COLORED CASTING TAPE CARAGLAS(TM GREEN (K874880) | Synthetic Mfg., Inc. | 1987-12-30 |
| PEDESTAL WALKING HEEL PRODUCT NO. 4183-133 (K873722) | Martin Medical | 1987-10-02 |
Recalls involving this device
No recalls on record reference this clearance.