GAUZE SPONGE
FDA 510(k) clearance K953812 · decided 1995-10-02
Clearance details
- K-number
- K953812
- Device name
- GAUZE SPONGE
- Applicant
- Remington Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-08-02
- Decision date
- 1995-10-02
- Days to decision
- 61 days
- Clearance type
- Traditional
- Product code
- KHR
- Device class
- 1
- Regulation number
- 872.6050
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Atlanta, GA, 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 |
|---|---|---|
| SIMPLEX SALIVA ABSORBER/COLLECTOR, MODEL SSA-5 (K980783) | Irt Management Corp. | 1998-04-21 |
| GENERAL HYGIENE KIT (K954068) | Physician Industries, Inc. | 1995-11-08 |
| NON-STERILE GAUZE SPONGE (K891054) | Dispomed, Inc. | 1989-05-01 |
| ORTHODONTIC COTTON ROLL HOLDERS (K891354) | American Orthodontics | 1989-04-17 |
| DRY TIPS (K890734) | Microcopy, Div. Neo-Flo, Inc. | 1989-03-10 |
| ALGINATE WOOL FIBER (K870383) | Adri | 1987-04-30 |
| BOVO MOISTURE GUARD (K850988) | E.H. Medical Co. | 1985-04-16 |
| DEN-Z-ORB (K780400) | Nice-Pak Products, Inc. | 1978-03-27 |
| ISO-SHIELD SALIVA ABSORBERS (K771908) | 3M Company | 1977-11-07 |
Recalls involving this device
No recalls on record reference this clearance.