MICRO-TORQUE HAND ENGINE & ACCESS. DERMABRA. BURS
FDA 510(k) clearance K873475 · decided 1987-09-11
Clearance details
- K-number
- K873475
- Device name
- MICRO-TORQUE HAND ENGINE & ACCESS. DERMABRA. BURS
- Applicant
- Mcghan Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 1987-08-31
- Decision date
- 1987-09-11
- Days to decision
- 11 days
- Clearance type
- Traditional
- Product code
- GEY
- Device class
- 1
- Regulation number
- 878.4820
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Santa Barbara, CA, US
- Third-party review
- No
- Expedited review
- No
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| BONE & MARROW CLLECTION SYSTEM (K971268) | Biomedical International Corp. | 1997-07-03 |
| ORTHOCHUCK (K964252) | Buckman Co., Inc. | 1997-05-27 |
| ANSPACH LUBRICATING SYSTEM II (K970530) | The Anspach Effort, Inc. | 1997-05-05 |
| BME BONE DRILL BITS (K964073) | Biomedical Ent., Inc. | 1996-11-14 |
| SURGICAL KIT-ACUFEX MOSAICPLASTY SYSTEM (K962789) | Smith & Nephew Endoscopy, Inc. | 1996-08-14 |
| BONE & MARROW COLLECTION SYSTEM (K961901) | Biomedical Ent., Inc. | 1996-08-06 |
Recalls involving this device
No recalls on record reference this clearance.