CUSTOM TRAYS, KITS
FDA 510(k) clearance K894610 · decided 1990-03-15
Clearance details
- K-number
- K894610
- Device name
- CUSTOM TRAYS, KITS
- Applicant
- L H M Ent., Inc.
- Decision
- Unknown
- Date received
- 1989-07-20
- Decision date
- 1990-03-15
- Days to decision
- 238 days
- Clearance type
- Traditional
- Product code
- FSM
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Palm Harbor, FL, US
- Third-party review
- No
- Expedited review
- No
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| HEART CATH TRAY (K912052) | Medical Device Inspection Co., Inc. | 1991-08-20 |
| MAJOR BASIN TRAY (K912104) | Medical Device Inspection Co., Inc. | 1991-08-09 |
| SPLINTER TWEEZERS (K910570) | Solan Scissors Sales | 1991-05-31 |
| REDDICK TROCAR AND CANNULA (K911601) | Ideal Medical, Inc. | 1991-05-21 |
| KEY COMFORT GRIPS (K910328) | Key Surgical, Inc. | 1991-03-06 |
| RICHARD-ALLAN CLAMP COVERS (K905682) | Richard-Allan Medical | 1991-02-19 |
| HAND SURGERY AND IRRIGATION TRAY (MODEL 3625) (K900376) | Pmt Corp. | 1990-04-10 |
Recalls involving this device
No recalls on record reference this clearance.