MODEL 545-45 FOR NEUROLOGICAL SURGICAL APPLICATION
FDA 510(k) clearance K860977 · decided 1986-10-16
Clearance details
- K-number
- K860977
- Device name
- MODEL 545-45 FOR NEUROLOGICAL SURGICAL APPLICATION
- Applicant
- Britt Corp., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-03-14
- Decision date
- 1986-10-16
- Days to decision
- 216 days
- Clearance type
- Traditional
- Product code
- LLF
- Device class
- 3
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Smithtown, NY, 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 |
|---|---|---|
| ENDOCOAGULATOR MODELS 5, 8 & 20 ARGON LASER (K870773) | Hgm, Inc. | 1987-07-10 |
| CILAS YM 101 ND:YAG LASER FOR NEUROLOGICAL USE (K864610) | Inframed, Inc. | 1987-06-18 |
| COOPER MEDICAL MODEL 770 (K833497) | Cooper Medical Corp. | 1984-04-17 |
Recalls involving this device
No recalls on record reference this clearance.