DENTAL COTTON ROLLS
FDA 510(k) clearance K841327 · decided 1984-07-03
Clearance details
- K-number
- K841327
- Device name
- DENTAL COTTON ROLLS
- Applicant
- Intl. Verbandstoff-Fabrik Schaffhau
- Decision
- Substantially Equivalent
- Date received
- 1984-04-02
- Decision date
- 1984-07-03
- Days to decision
- 92 days
- Clearance type
- Traditional
- Product code
- EFN
- Device class
- 1
- Regulation number
- 872.6050
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Walker, MI, 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 |
|---|---|---|
| STRUNG DENTAL ROLLS (K872810) | American Silk Sutures, Inc. | 1987-12-04 |
| MEDGROUP ENTERPRISES COTTON GAUZE SPONGES-NON STER (K871464) | Medgroup Enterprises, Inc. | 1987-04-30 |
| COTTON ROLLS, NON-STERILE (K863764) | The Medical Group, Inc. | 1986-10-27 |
| DENTAL COTTON ROLLS, STERILE AND NON-STERILE (K861338) | Intl. Verbandstoff-Fabrik Schaffhau | 1986-08-06 |
| COTTON FILLED GAUZE SPONGES 2 X 2 (K861727) | Cross Country Paper Products Corp. | 1986-07-10 |
| TELEDYNE DENSCO DRY TIPS SALIVA ABSORB- (K843539) | Molnlycke A/S Hospital Products | 1985-05-23 |
| SCHEIN COTTON ROLLS, NON-STERILE (K834056) | Henry Schein, Inc. | 1984-02-03 |
| STERILE COTTON ROLLS #3, 1 1/2 (K830175) | Veratex Corp. | 1983-02-18 |
| STERILE DENTAL ROLL (K812709) | Medspec Corp. | 1981-10-23 |
| HOYT COTTON ROLLS (K810830) | Hoyt Laboratories | 1981-04-14 |
| COTTON ROLLS (K802429) | Worldwide Surgical Gauze | 1980-10-23 |
| COTTON ROLL COMPRESSION CAPS (K792391) | Parker Laboratories, Inc. | 1979-12-06 |
Recalls involving this device
No recalls on record reference this clearance.