The following data is part of a premarket notification filed by Pinnacle Products, Inc. with the FDA for Cover-all, Drape-it-all, Chair Sleve, X-ray Sleeve, Headrest Cover.
| Device ID | K962288 |
| 510k Number | K962288 |
| Device Name: | COVER-ALL, DRAPE-IT-ALL, CHAIR SLEVE, X-RAY SLEEVE, HEADREST COVER |
| Classification | Cover, Barrier, Protective |
| Applicant | PINNACLE PRODUCTS, INC. 624 SOUTH SMITH AVE. St. Paul, MN 55107 |
| Contact | Thomas Lasing |
| Correspondent | Thomas Lasing PINNACLE PRODUCTS, INC. 624 SOUTH SMITH AVE. St. Paul, MN 55107 |
| Product Code | MMP |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-14 |
| Decision Date | 1997-01-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D6620708508002 | K962288 | 000 |
| D6620708507502 | K962288 | 000 |
| D6620708506932 | K962288 | 000 |
| D6620708506692 | K962288 | 000 |