DISPOSABLE RADIOLUCENT RUBBER DAM CLAMP
FDA 510(k) clearance K915207 · decided 1992-02-14
Clearance details
- K-number
- K915207
- Device name
- DISPOSABLE RADIOLUCENT RUBBER DAM CLAMP
- Applicant
- Bay Technical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-11-18
- Decision date
- 1992-02-14
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- EEF
- Device class
- 1
- Regulation number
- 872.6300
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Fremont, CA, 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 |
|---|---|---|
| FIXAFLOSS (K071615) | Sybron Dental Specialties, Inc. | 2007-09-21 |
| BRINKER TISSUE RETRACTORS (K780744) | Hygienic Dental Mfg., Co., The | 1978-05-12 |
Recalls involving this device
No recalls on record reference this clearance.