SPECULITE DISPOSABLE VAGINAL LIGHT
FDA 510(k) clearance K853257 · decided 1985-12-27
Clearance details
- K-number
- K853257
- Device name
- SPECULITE DISPOSABLE VAGINAL LIGHT
- Applicant
- Trylon Associates, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1985-08-02
- Decision date
- 1985-12-27
- Days to decision
- 147 days
- Clearance type
- Traditional
- Product code
- HIC
- Device class
- 2
- Regulation number
- 884.4530
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Harbor City, 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 |
|---|---|---|
| PAP PLUS SPECULOSCOPY COMPREHENSIVE PELVIC EXAM TRAY (K955790) | Trylon Corp. | 1996-03-21 |
| LIGHTING SOURCE SYSTEM (K923656) | Galenica Enterprises, Inc. | 1994-09-08 |
| NEW LENGTH SUGITA APPLIERS (K902516) | Sims Surgical, Inc. | 1990-07-03 |
| CENTURION VAGINAL SPECULUM (K897100) | Tri-State Hospital Supply Corp. | 1990-03-16 |
Recalls involving this device
No recalls on record reference this clearance.