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#
- 3038283966
- 3040391047
- 1423537
- 3013518061
- 3016685880
- 1063851
- 3003674698
- 3006538822
- 9615551
- 3006795808
- 3013440654
- 3004713352
- 9680708
- 3014257280
- 3016955900
- 3010147274
- 3008770063
- 3017417635
- 3015477649
- 3016248634
- 9616765
- 3008311433
- 3009009512
- 3040362701
- 3008191396
- 9613910
- 3005997949
- 1047843
- 3005599545
- 2433012
- 3011427127
- 3011559089
- 3013351831
- 3007594755
- 1054241
- 3013019728
- 3008868758
- 3004930567
- 2954935
- 1928237
- 8041180
- 3009135447
- 3009233038
- 3008770655
- 3012595397
- 3043051412
- 3005558160
- 3006534724
- 1528440
- 9710505
- 3019848304
- 9611959
- 3005214422
- 3007050292
- 1057404
- 3008044472
- 3015532203
- 3017375560
- 3006123105
- 9710613
- 3007134585
- 3011772765
- 3023339277
- 3014601456
- 3010774780
- 3010864832
- 3014198412
- 3017412411
- 3016099060
- 3009605026
- 8043467
- 3044466317
- 1036836
- 3009736246
- 2530138
- 3015416207
- 3008489813
- 3017461111
- 3011205500
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 |