DISPOSABLE BASE MOLD
FDA 510(k) clearance K831335 · decided 1983-05-16
Clearance details
- K-number
- K831335
- Device name
- DISPOSABLE BASE MOLD
- Applicant
- Surgipath Medical Industries, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-04-25
- Decision date
- 1983-05-16
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- KER
- Device class
- 1
- Regulation number
- 864.3010
- Medical specialty
- Pathology
- Advisory committee
- Pathology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Surgipath Medical Industries
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| EMBEDDING RING (K831922) | Polymer Technology Corp. | 1983-07-29 |
| MACLEAN-FOGG, DISP. BASE MOLD (K831900) | Polymer Technology Corp. | 1983-07-28 |
| EMBEDDING RINGS (K831333) | Surgipath Medical Industries, Inc. | 1983-05-25 |
| LANCER BIOPSY HOLDER (K772149) | Sherwood Medical Industries | 1977-11-22 |
Recalls involving this device
No recalls on record reference this clearance.