SURGICAL TRAY (STERILE)
FDA 510(k) clearance K925022 · decided 1993-04-26
Clearance details
- K-number
- K925022
- Device name
- SURGICAL TRAY (STERILE)
- Applicant
- Customed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-09-24
- Decision date
- 1993-04-26
- Days to decision
- 214 days
- Clearance type
- Traditional
- Product code
- LRD
- Device class
- 1
- Regulation number
- 874.5220
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Fajardo, PR, 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 |
|---|---|---|
| AROMAPATCH (K984345) | Envis, Inc. | 1999-03-19 |
| AMSCO STERILE RECOVERIES SURGICAL PACKS (K932522) | Amsco Sterile Recoveries, Inc. | 1994-09-09 |
| MISTASSIST (K942789) | The Merlin Corp. | 1994-08-12 |
| THE EXPANDACELL EAR PACK (K940133) | Denver Splint Co. | 1994-05-23 |
| AEROSOL DELIVERY SYSTEMS (K920842) | Hospitak, Inc. | 1992-05-15 |
Recalls involving this device
No recalls on record reference this clearance.