CUSTOM INSTRUMENT DRAPE
FDA 510(k) clearance K843890 · decided 1984-10-26
Clearance details
- K-number
- K843890
- Device name
- CUSTOM INSTRUMENT DRAPE
- Applicant
- Lifestream Int'L, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-10-02
- Decision date
- 1984-10-26
- Days to decision
- 24 days
- Clearance type
- Traditional
- Product code
- HMW
- Device class
- 2
- Regulation number
- 878.4370
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Sugar Land, TX, 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 |
|---|---|---|
| INVOTEC MICROSCOPE DRAPE (K911040) | Invotec International, Inc. | 1991-06-03 |
| STERILE INSTRUMENT DRAPE (K902763) | North American Sterilization & Packaging Co. | 1990-09-20 |
| MICROSCOPE DRAPE (K902851) | Medical Technique Instruments, Inc. | 1990-09-10 |
Recalls involving this device
No recalls on record reference this clearance.