LYU — Accessory, Surgical Apparel Class I
FDA product code LYU covers "Accessory, Surgical Apparel", a Class I medical device regulated under 21 CFR 878.4040. Submissions are reviewed by the General, Plastic Surgery panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LYU
- Device Class
- Class I
- Regulation Number
- 878.4040
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K011755 | stryker | STRYKER T4 HYTREL (R) TOGAS | June 22, 2001 |
| K965237 | copioumed intl | NURSES BOUFFANT CAP | August 27, 1997 |
| K970988 | far east science and technology development co | FAR-EAST BOUFFANT CAPS | July 10, 1997 |
| K964364 | instrument makar | DISPOSABLE APRON | February 25, 1997 |
| K961791 | depuy | DEPUY DISPOSABLE FILTER/HOOD | August 9, 1996 |
| K961454 | american medical mfg | AMMI MAGNI-GUARD | July 25, 1996 |
| K945302 | sloan | SLOAN STA-DRI PANT PROTECTOR | March 19, 1996 |
| K954314 | stahmer weston scientific | ULTRAFIT LINERS | December 28, 1995 |
| K953089 | products for medicine | I-SPOUSE | October 16, 1995 |
| K952303 | innovative outsourcing solutions | SPLASH ASSIST | August 24, 1995 |
| K942200 | thantex specialties | ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPS | August 7, 1995 |
| K944118 | sloan | SLOAN STA-DRI SURGICAL JUMPSUIT | July 31, 1995 |
| K944276 | sloan | SLOAN STA-DRI BOOTLEG LEGGING | July 31, 1995 |
| K946003 | intec industries | INTEC FULL FACE SHIELD | June 28, 1995 |
| K951420 | alpha surgical | INCASE EXTENSIBLE BAG--NON-STERILE | June 8, 1995 |
| K944763 | wells lamont | CUT-TEC OR WELLS LAMONT POLYESTER/WIRE CUT-RESISTANT GLOVE LINER WELLS-TEC, SCEP | April 10, 1995 |
| K945098 | op-d-op visor shields | OP-D-OP II | February 28, 1995 |
| K942828 | instrument makar | MAKAR FULL AND HALF FACE SHIELD | February 23, 1995 |
| K943809 | white knight healthcare | MONOGARD FACE SHIELD | November 28, 1994 |
| K940228 | derekduck industries | BOUFFANT CAP | September 26, 1994 |