510(k) K961791
- Device
- Depuy Disposable Filter/hood
- Applicant
- DEPUY, INC.
- 510(k) number
- K961791
- Product code
- LYU
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-08-09
- Date received
- 1996-05-09
- Regulation
- 878.4040
- Classification name
- Accessory, Surgical Apparel
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CHERYL HASTINGS
- Address
- 700 Orthopaedic Dr. Warsaw IN US 46581 46581
FDA Registration Numbers#
- 9680794
- 3017095924
- 9616765
- 3008044484
- 3006750986
- 3026979361
- 3013496867
- 3018269545
- 3027605742
- 3044737675
- 3006055831
- 3018781093
- 3013388519
- 3013123550
- 9710613
- 3010334650
- 3017597597
- 3005841027
- 3003835287
- 3015092134
- 3033011342
- 3017385563
- 3001124136
- 3016426851
- 1219113
- 3008868758
- 3039282838
- 3013524663
- 3013340866
- 3008562183
- 3009555608
- 2433012
- 3043226252
- 3012207247
- 3005739529
- 3015140199
- 3008973893
- 3013943846
- 3009542933
- 3016616327
- 3010288673
- 3009405889
- 3001650535
- 3017375560
- 3006723122
- 3020460367
- 3010595915
- 3030678923
- 3012520513
- 3017494285
- 3022121580
- 2435946
- 2182318
- 3013595964
- 3004598644
- 3009009512
- 1043646
- 3005271071
- 3017467279
- 3016686946
- 3004111573
- 3013518061
- 3008311433
- 3009560891
- 3011715978
- 8030654
- 3016450032
- 3009513193
- 3013657868
- 3013019728
- 3023435669
- 3017276640
- 3047906906
- 3006534724
- 3013513837
- 1926174
- 3011676045
- 3005621808
- 3024787345
- 3011307306
Source Documents#
Other 510(k) Records For Product Code LYU#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K011755 | STRYKER T4 HYTREL (R) TOGAS | Stryker Corp. | 2001-06-22 |
| K965237 | NURSES BOUFFANT CAP | Copioumed Intl., Inc. | 1997-08-27 |
| K970988 | FAR-EAST BOUFFANT CAPS | Far East Science & Technology Development Co., Ltd. | 1997-07-10 |
| K964364 | DISPOSABLE APRON | Instrument Makar, Inc. | 1997-02-25 |
| K961454 | AMMI MAGNI-GUARD | American Medical Mfg., Inc. | 1996-07-25 |
| K945302 | SLOAN STA-DRI PANT PROTECTOR | Sloan Corp. | 1996-03-19 |
| K954314 | ULTRAFIT LINERS | Stahmer Weston Scientific | 1995-12-28 |
| K953089 | I-SPOUSE | Products For Medicine | 1995-10-16 |
| K952303 | SPLASH ASSIST | Innovative Outsourcing Solutions | 1995-08-24 |
| K942200 | ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPS | Thantex Specialties, Inc. | 1995-08-07 |
| K944118 | SLOAN STA-DRI SURGICAL JUMPSUIT | Sloan Corp. | 1995-07-31 |
| K944276 | SLOAN STA-DRI BOOTLEG LEGGING | Sloan Corp. | 1995-07-31 |
| K946003 | INTEC FULL FACE SHIELD | Intec Industries, Inc. | 1995-06-28 |
| K951420 | INCASE EXTENSIBLE BAG--NON-STERILE | Alpha Surgical, Inc. | 1995-06-08 |
| K944763 | CUT-TEC OR WELLS LAMONT POLYESTER/WIRE CUT-RESISTANT GLOVE LINER WELLS-TEC, SCEPTER | Wells Lamont Corp. | 1995-04-10 |