The following data is part of a premarket notification filed by Medical Creative Technologies, Inc. with the FDA for Dexterity Pneumo Sleeve Set.
| Device ID | K962147 |
| 510k Number | K962147 |
| Device Name: | DEXTERITY PNEUMO SLEEVE SET |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | MEDICAL CREATIVE TECHNOLOGIES, INC. 2950-N ADVANCE LN. Colmar, PA 18915 -9727 |
| Contact | Perk Crook |
| Correspondent | Perk Crook MEDICAL CREATIVE TECHNOLOGIES, INC. 2950-N ADVANCE LN. Colmar, PA 18915 -9727 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-03 |
| Decision Date | 1996-07-09 |
| Summary: | summary |